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177 Microbiome Trials Near You
Power is an online platform that helps thousands of Microbiome patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerComplementary Feeding for Infant Growth and Gut Health
Aurora, Colorado
This study plans to learn more about how consuming different foods during the time of early complementary feeding (\~5 to 12 months) affects growth and the development of bacteria living inside your baby's gut through school-age. The results from this study will potentially help to support future recommendations and dietary guidance for infant feeding practices.
The three primary aims include:
Aim 1. Identify the impact of dietary patterns with different protein-rich foods on infant growth.
Aim 2. Identify the impact of dietary patterns with different protein-rich foods on infant gut microbiota development.
Aim 3. Identify gut microbial taxa and genes that affect infant growth.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:4 - 60
Key Eligibility Criteria
Disqualifiers:Pre-term, Growth Conditions, Others
Must Not Be Taking:Antibiotics
267 Participants Needed
Acetate Supplements for Age-Related Vascular Stiffness
Aurora, Colorado
Cardiovascular diseases are the leading cause of morbidity and mortality and contribute most to healthcare costs in the U.S. Age is the strongest cardiovascular disease risk factor, with \>90% of all deaths from cardiovascular disease occurring in adults \>50 years old. The age-associated increased risk of cardiovascular disease is due, in large part, to the development of arterial dysfunction, including endothelial dysfunction and stiffening of the large elastic arteries. Therefore, novel, effective interventions that improve arterial function will have a large public health impact by decreasing the risk of cardiovascular diseases.
The short-chain fatty acid acetate is endogenously produced by the gut microbiome from fermentation of dietary soluble fiber. High-fiber diets reduce risk of cardiovascular diseases, but unfortunately, a low percentage of Americans meet guidelines for adequate dietary fiber intake and, despite nationwide efforts to improve this, trends in fiber intake have not improved over the last 20+ years. Thus, directly supplementing acetate may be a more practical and feasible intervention for effectively improving arterial function in older adults and reducing the risk of cardiovascular diseases.
The investigators will conduct a study to determine the efficacy of 12 weeks of oral supplementation with acetate for improving arterial function in late middle-aged and older (50+ years) adults. They will also assess the safety and tolerability of acetate supplementation in these adults and perform innovative mechanistic analyses to determine how acetate supplementation improves arterial function. The investigators hypothesize that oral acetate supplementation will improve arterial function by decreasing oxidative stress and increasing nitric oxide bioavailability, and also hypothesize that acetate supplementation will be safe and promote high rates of adherence.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:50+
Key Eligibility Criteria
Disqualifiers:Cardiovascular Disease, Diabetes, Cancer, Others
Must Not Be Taking:Calcium Supplements
66 Participants Needed
Mediterranean Diet vs Western Diet for Healthy Eating Habits
Aurora, Colorado
This study plans to learn more about how consuming a diet with foods typical to a Mediterranean Diet such as whole grains, fruits and vegetables in a Western-style diet compares to eating a typical Western-style diet. This study will look at how diet affects overall health including risk factors for heart disease, gut health and inflammation as well as underlying mechanisms linking whole food to health. Findings from this study will potentially inform effective dietary recommendations and interventions, thereby reducing chronic disease in humans.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Age:30 - 69
Key Eligibility Criteria
Disqualifiers:Not Listed
22 Participants Needed
Milk + Yogurt for Bone Health
Saskatoon, Saskatchewan
Milk and dairy products contain significant amounts of nutrients that contribute to optimal health - nutrients like calcium, vitamin D, and high-quality protein. Fermented milk products or fermented dairy products are dairy foods that have been fermented with certain bacteria. Yogurt is a fermented dairy product containing millions of beneficial bacteria. In this study, the invesgitagtors will look at the effect of milk (a non-fermented dairy product) and yogurt (a fermented dairy product) supplementation on bone health and the amount of fat and muscle mass in Canadian young adults over a 24-month period. While dairy products contain significant amounts of nutrients, the scientific community does not know the impact of long-term supplementation of fermented (i.e., yogurt) or non-fermented (i.e., milk) dairy food on bone health and the amount of fat and muscle mass in young adults. To fill this knowledge gap, the investigators will recruit participants with low calcium intake and assign them to three different groups: 1) milk (intervention) group; 2) yogurt (intervention) group; and 3) control group. The investigators will ask the participants in the milk group to drink 1.5 servings (375 mL) of milk per day for 24 months. Participants in the yogurt group will consume 2 servings (350 g) of yogurt per day for 24 months. Those in the control group will continue their usual diets. Using a randomized controlled trial design, the investigators will measure bone health parameters, hormonal indices related to bone metabolism, body composition (e.g., muscle mass, fat mass), and the number and composition of bacteria living in the gastrointestinal (GI) tract. The hypothesis is that supplementation with yogurt will have more positive effects on bone health indices, particularly femoral neck BMD as the primary outcome, than milk in Canadian adults aged 19-30 years. The secondary hypothesis is that supplementation with yogurt, as a fermented milk product, will have a more beneficial effect than milk on body composition measures. The data will provide valuable information for developing targeted health initiatives and marketing strategies regarding the benefits of fermented and non-fermented dairy product consumption.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:19 - 30
Key Eligibility Criteria
Disqualifiers:High Calcium Intake, High BMI, Others
Must Not Be Taking:Steroids, Diuretics, Heparin, Cancer Drugs
99 Participants Needed
This trial compares the health effects of eating foods from eco-friendly farms versus regular farms in middle-aged adults. Researchers will look at changes in inflammation and metabolism by analyzing blood, urine, and stool samples. The goal is to see if the eco-friendly diet offers better health benefits.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Age:35 - 60
Key Eligibility Criteria
Disqualifiers:Not Listed
34 Participants Needed
IgY Supplement for Immune System Support
Calgary, Alberta
This study is to evaluate whether Muno-IgY is effective in enhancing immune health among adults over a six week period.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Gastrointestinal Disease, Cancer, Immunological Disease, Others
Must Not Be Taking:Antidepressants, Antipsychotics, Antihypertensives, Others
20 Participants Needed
Donor Human Milk for Infant Gut Health
Calgary, Alberta
This trial is testing whether giving donor human milk instead of formula to full-term infants can help maintain healthy gut bacteria. The study aims to see if this can improve the babies' sleep, growth, and overall health. The trial also looks at how this affects the mothers' mental health and breastfeeding success.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:37+
Key Eligibility Criteria
Disqualifiers:Major Congenital Malformation, Others
Must Not Be Taking:Extended Antibiotics
105 Participants Needed
Nutritional Supplement for Type 2 Diabetes
Calgary, Alberta
This is a single-arm interventional clinical study, the primary objective is to assess the changes in the small intestinal (SI) metagenomic profile of in diabetic participants from baseline to midpoint and endpoint in response to the ONS intervention. The study population is Type 2 Diabetes (T2D) participants (n=30) who will ingest an Oral Nutritional Supplement (ONS) .
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1
Age:40 - 65
Key Eligibility Criteria
Disqualifiers:Type 1 Diabetes, Renal Disease, Hepatic Disease, Cancer, Others
Must Be Taking:Metformin
30 Participants Needed
Iron Supplements for Iron Deficiency
Calgary, Alberta
The goal of this clinical trial is to learn if different types and doses of oral iron supplements can improve iron levels, athletic performance, and gut health in young female athletes with low iron stores. The main questions it aims to answer are:
* Does a low dose of yeast-bound iron improve iron status better than traditional iron supplements?
* Do the different iron supplements cause fewer or more gastrointestinal (stomach) symptoms?
* How do iron supplements affect exercise performance and gut bacteria?
Researchers will compare three types of iron supplements:
* A low-dose iron supplement (40 mg)
* A low-dose yeast-bound iron supplement (40 mg)
* A high-dose iron supplement (150 mg)
This will help researchers find out which type of supplement is most effective and easiest on the stomach.
Participants will:
* Take one of the three assigned iron supplements every other day for 12 weeks
* Complete fitness tests before and after the study, including cycling and jumping tests
* Give blood samples to measure iron levels
* Provide stool and intestinal samples to study gut bacteria
* Swallow a SIMBA capsule before and after the study to collect a sample from the small intestine
* Complete regular online surveys about sleep, stress, menstrual cycles, and gut symptoms
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:16 - 35
Sex:Female
Key Eligibility Criteria
Disqualifiers:Anemia, Smoking, Alcohol, Others
Must Not Be Taking:Antibiotics, Antacids, NSAIDs, Others
36 Participants Needed
Anti-Inflammatory Fibres for Ulcerative Colitis
Edmonton, Alberta
The goal of this clinical trial is to determine the clinical effects of two different dietary fibre supplements, acacia gum (AG) and microcrystalline cellulose (MCC), in patients with ulcerative colitis. The main question it aims to answer is: Can the fibre supplements reduce gut inflammation (fecal calprotectin)?
Researchers will compare AG and MCC to a placebo (a look-alike substance that contains no fibre) to see if the fibre supplements improve inflammation in ulcerative colitis.
Participants will add their assigned fibre supplement or placebo to their usual diet daily for 6 weeks. They will visit the clinic at baseline, week 3, and week 6 to provide samples (stool, blood) and complete various questionnaires.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:15 - 60
Key Eligibility Criteria
Disqualifiers:Crohn Disease, Celiac, Pregnancy, Others
Must Not Be Taking:Antibiotics, Probiotics, Prebiotics, Others
69 Participants Needed
Fecal Microbiota Transplant for Ulcerative Colitis
Edmonton, Alberta
To compare the safety and efficacy of concomitant LFMT versus placebo in UC patients who are starting vedolizumab or ustekinumab.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Severe UC, Indeterminate Colitis, Others
Must Be Taking:Vedolizumab, Ustekinumab
40 Participants Needed
Inflammatory bowel disease (IBD) is a chronic illness characterized by inflammation of the intestine. Many individuals with IBD suffer from depressive symptoms and anxiety which can lead to a decreased quality of life, poor treatment compliance, and higher morbidity and mortality. The object of this clinical trial is to investigate the effects of a fasting mimicking diet in IBD patients who are suffering with symptoms of depression. Participants will carry out 3 cycles of a 5-day period of a plant-based low caloric diet or a plant-based caloric sufficient diet following by 3 weeks of eating normally. Effects of the dietary intervention on microbes in the gut, immune and metabolic function, and depressive symptoms will be measured. The overall goal is to develop a safe and effective treatment to improve mental health in patients with IBD by targeting the gut microbiome through dietary interventions.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Early Phase 1
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Diabetes, Celiac, Psychotic, Others
120 Participants Needed
Endurance Training for Healthy Individuals
Kelowna, British Columbia
The purpose of this study is to investigate the effect of 12-months of individualized endurance-training (swimming, cycling and running) on physiological and psychological adaptations in exercise naïve individuals. Due to the potential seasonal changes that naturally occur in individuals across a year (even without training) the investigators will also compare the exercise-trained group to a time-aligned control group.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:19 - 39
Key Eligibility Criteria
Disqualifiers:Heart Disease, Lung Disease, Metabolic Disease, Cancer, Others
Must Not Be Taking:Antibiotics, Antivirals, NSAIDs, Antihistamines
60 Participants Needed
Mediterranean Diet for Healthy Subjects
Kelowna, British Columbia
People respond differently to various diets-some may see significant benefits, while others may not. This project aims to personalize dietary recommendations by analyzing the gut microbiome to predict who will benefit most from the Mediterranean diet based on their unique biology, including their microbiome.
The study focuses on answering these key questions:
1. Are there specific microbes that influence who is most likely to benefit from the Mediterranean diet?
2. What changes occur in the gut microbiome when healthy individuals follow a Mediterranean diet?
To explore these questions, researchers will compare the effects of a Mediterranean diet to a Western-style diet. Participants will receive all their meals and snacks for the study to ensure accurate comparisons of how these diets impact the gut microbiome.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:20 - 50
Key Eligibility Criteria
Disqualifiers:Irritable Bowel Syndrome, Diabetes, Food Allergies, Others
Must Not Be Taking:Oral Antibiotics
25 Participants Needed
Fruit Consumption for Gut Health
San Diego, California
The objectives of this study are to investigate the effect of fruit consumption on the gut microbiota and their collective fecal and plasma metabolomes, vascular and cardiometabolic functions, cognition, and motor control.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Age:30 - 70
Key Eligibility Criteria
Disqualifiers:Not Listed
40 Participants Needed
Mango for Gut Microbiome
San Diego, California
The objective of the proposed research is to determine the effects of fresh mango consumption on gut microbiome, and its relationship with skin health, sexual and mental health in relatively healthy adults.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 50
Key Eligibility Criteria
Disqualifiers:Smoker, Pregnant, Mango Allergy, Others
Must Not Be Taking:Antibiotics, Dietary Supplements, Others
60 Participants Needed
CBD + THC for HIV/AIDS
San Diego, California
This study has the potential to contribute to a more complete understanding of the independent and combined effects of cannabis use and HIV on the brain and on inflammation. Such knowledge may inform future strategies for treating brain disease and inflammation. Participants will be randomly assigned to one of two groups, both of which will receive the same treatment in a different order over a period of about 6 weeks. The visits include physical examinations, blood tests, and other procedures designed to monitor subject safety and measure the effects of the study drug.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:21 - 70
Key Eligibility Criteria
Disqualifiers:Substance Use Disorder, Dementia, Pregnancy, Cardiovascular Risk, Others
Must Be Taking:ART
90 Participants Needed
Mediterranean Diet for Inflammation Post-Colonoscopy
San Diego, California
This study aims to investigate the impact of various healthy diets, specifically a modified plant-based Mediterranean diet, on the gut microbiome and overall well-being post-colonoscopy. The investigators hypothesize that certain diets can positively influence gut bacteria, reducing inflammation and enhancing metabolic signals.
To explore this, they will utilize metagenomic testing on stool samples to analyze the DNA of gut microorganisms. Additionally, they will conduct immune profiling on serum samples and perform metabolomic analysis to comprehensively evaluate the diet-induced changes in immune response and metabolic pathways. This multi-faceted approach will help them understand how dietary changes affect the composition and function of the gut microbiome, immune function, and overall metabolism.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Pregnant, Diabetes, Hypertension, Psychiatric Disorders, Others
Must Not Be Taking:Antibiotics, Insulin, Sulfonylureas, Glinides
30 Participants Needed
Nutritional Counseling for Breast Cancer
La Jolla, California
The gut microbiome is made up of the microbes (such as bacteria, viruses, and other organisms too small to see with the naked eye) that live in the digestive tract and has been shown to be important in metabolizing food, extracting vitamins and nutrients from food, and maintaining a healthy gut lining. The gut microbiome plays an important role in overall health and has been shown to dynamically change in response to early-stage triple-negative breast cancer-directed therapies, which in turn has been associated with worse outcomes. As the gut microbiome can be further modulated with dietary changes during cancer treatment, it is an ideal potential modifiable risk factor in cancer patients. However, due to multiple confounding factors such as dietary intake, mood, and activity, its utility as part of the oncologic clinical assessment remains unclear.
In this prospective randomized controlled study, the investigators propose to recruit up to 30 early-stage TNBC patients to randomize to a personalized nutritional intervention of a high-fiber diet coached by a registered dietician versus educational handout alone during neoadjuvant treatment. The investigators propose to study the gut microbiota through stool sample analysis among early-stage triple-negative breast cancer patients undergoing neoadjuvant (i.e. before surgery) chemotherapy +/- immunotherapy. The investigators will also study how the gut microbiota can be further modulated with a high-fiber diet, and the investigators hypothesize that a high-fiber diet may play a protective role in preserving gut microbial diversity. As part of the nutritional intervention, the investigators propose to administer nutritional counseling with a registered dietitian (RD) to increase fiber intake and tracking performance status, activity, and mood during neoadjuvant treatment. Finally, the investigators propose to survey participants after study completion through one-on-one interviews to determine whether participants experienced improved overall patient satisfaction in supportive care during their treatment.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Non-early-stage TNBC, Others
Must Not Be Taking:Prebiotics, Probiotics
30 Participants Needed
CBM588 + Nivolumab/Ipilimumab for Kidney Cancer
Duarte, California
This is a single arm open-label phase 1 study evaluating the safety and efficacy of escalating doses of CBM588 in combination with nivolumab and ipilimumab. A standard 3+3 dose escalation schema will be used initially to assess the maximum tolerated dose (MTD) followed by a dose expansion of 10 patients at the MTD to further evaluate safety and efficacy.
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Key Eligibility Criteria
Disqualifiers:Interstitial Lung Disease, Brain Metastases, Autoimmune Disease, Others
Must Not Be Taking:Probiotics, Yogurt
28 Participants Needed
Why Other Patients Applied
"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."
ID
Pancreatic Cancer PatientAge: 40
"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."
FF
ADHD PatientAge: 31
"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."
AG
Paralysis PatientAge: 50
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."
HZ
Arthritis PatientAge: 78
Mouthrinses for Oral Microbiome Health
Irvine, California
The purpose of this research study is to identify the effects of 2 over-the-counter mouthwashes on bacteria and 3 viruses in the participant's mouth and gut. The participant will be randomly allocated to rinse their mouth twice daily either with Listerine mouthwash, Lumineux Oral Essentials mouthwash, or water. The overall duration of the study will be approximately 180 days and will include approximately 5 visits and 15-30 minutes for each visit with a total of approximately 2.5 hours of your time. Additionally, fecal matter will also be collected in some subjects using a commercial collection kit.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Less Than 20 Teeth, Others
Must Not Be Taking:Antibiotics
200 Participants Needed
FMT for Autism
Los Angeles, California
The purpose of this study is to find out if transplant of fecal matter (stool), also known as fecal microbiota transplantation (FMT), from a healthy person into the intestines of children and young adults with Autism Spectrum Disorder (ASD).
For this study children between the ages of 5-17years will be recruited over 2 years. Children will be recruited who receive an ASD diagnosis using the gold-standard Autism Diagnosis Observation Schedule -2 (ADOS-2) using module 1, 2 or 3 (none, limited or no moderate expressive language). Children diagnosed with these modules of the ADOS-2 may be at greater risk for GI disorders and rigid-compulsive behaviors. Additional assessment of rigid-compulsive behaviors and social communication will be done using the Repetitive Behavioral Scales-Revised (RBS-R) and Social Responsiveness Scale-2 (SRS-2), respectively. KBIT (the Kaufman Brief Intelligence Test) is used at baseline to obtain patient IQ. Total evaluation time is approximately 90 minutes. Following baseline symptom evaluation, a medical exam will be performed to determine whether each child is expressing specific GI symptoms. In addition, parents will fill out the Questionnaire for Pediatric Gastrointestinal Symptoms- Rome III (QPGS-III). Once an ASD diagnosis is confirmed, FMT treatment will be initiated, which typically occurs within 4-6 weeks of the initial diagnosis. Half 50% of the children (n=5) will receive the equivalent of 50 g of stools from a healthy donor into the jejunum through upper endoscopy and the other 50% off children (n=5) will receive Saline solution as Placebo control through upper endoscopy.
Subjects will have a total of 5 visits within 24 weeks including phone call follow up on Day 7 after FMT.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1
Age:5 - 17
Key Eligibility Criteria
Disqualifiers:Renal Dysfunction, Liver Dysfunction, Immunodeficiency, Others
10 Participants Needed
Polyphenol Supplement for Cognitive Impairment
Los Angeles, California
Globally, populations are aging thereby increasing healthcare burden, overall cognitive impairment, and dementia including Alzheimers diseases (AD). The lack of effective treatments makes it essential to develop new strategies for healthy cognitive aging, including interventions to slow or prevent cognitive decline. A traditional Mediterranean diet, rich in polyphenols (PPs), may prevent or delay the onset of cognitive dysfunction in older adults, preserving healthy brain structure and function, and lowering the risk of AD. These effects, mediated in part by gut microbiome-derived PP metabolites, highlight the role alterations in the brain-gut microbiome system play in neurodegeneration. Moreover, high levels of circulating phenyl-y-valerolactones, neuroprotective compounds, exclusively produced by gut microbiota from flavan-3-ol-rich foods (e.g., cocoa, tea, berries) are associated with delaying the onset of cognitive dysfunction in older adults. Intake of such PPs can also change gut microbial composition and function, altering the physiology of the hosts secondary bile acid (BA) pool, affecting regulatory and signaling functions in the brain as well as cognitive decline and AD. The investigators hypothesize that, in older adults with enhanced AD risk, dietary intake of PPs maintains healthier brain features and cognitive function, and that this beneficial effect is mediated by gut microbiota metabolites of PPs and BAs.
In this multi-PI application by leaders in the field of brain-gut microbiome interactions, the investigators will conduct a year-long, multi-center, randomized double-blind placebo-controlled study in 300 older adults in the United States (validation sample of 100 from Northern Ireland) who are at enhanced risk of developing AD. Ultimately, the investigators will establish the protective effects of regular dietary PP intake on cognitive function and on brain-gut microbiome interactions, ideally allowing the development of effective dietary regimes to prevent of delay the onset of AD in at-risk elderly, thereby reducing cognitive decline and healthcare costs.
Participants will be asked to provide information about their diet, mood, and behaviors via food diaries, physical body measures (e.g. height, weight, etc.), and online questionnaires collected before each in-clinic appointment, as well as monthly online questionnaires. MR imaging will be collected on participants to assess neurocognitive changes as a result of the supplement. Participants will be asked to provide both stool and blood samples. Participants will be randomly assigned to either the Juice Plus+ intervention group or the placebo treatment group and then asked to take their respective supplement 4 pills twice a day. All participants will be asked to come in for 4 in-clinic appointments, including 3 brain MRI scans and 3 cognitive testing appointments, collect 3 stool samples with corresponding diet diaries, and provide 3 blood samples over the course of 12 months. Participants will also meet with a nutritionist 3 times over the 12 months to discuss diet to ensure study eligibility and any questions about the supplement.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:50+
Key Eligibility Criteria
Disqualifiers:Vegan, Cognitive Impairment, Psychosis, Others
Must Not Be Taking:Psychoactive Medications, Antibiotics, Probiotics
300 Participants Needed
Endoscopic Fluid Collection for Small Intestinal Conditions
Los Angeles, California
The small intestine is an understudied frontier of microbiome research. While aspiration during endoscopy is considered the gold standard to assess small bowel bacteria, the tools for sterile retrieval are primitive and poorly validated.
Endoscopic aspiration is time-consuming and prone to contamination. Inspired by plants' ability to draw water by capillary action, a novel multi-capillary sterile system was designed which is a modified version of the conventional aspiration catheter.
The purpose of this study is to examine the time and volume capabilities of this catheter in suctioning various liquids compared to conventional aspiration catheter, in two groups, each includes 23 patients that going under endoscopy at GI lab at Cedars Sinai Medical Center. The investigator will collect up to 2 ml fluid from Duodenum- in first group by using the conventional catheter and in second group by using the capillary catheter. The time collection and the volume of samples in 2 groups will be compared.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
46 Participants Needed
Nutritional Supplement for Gastrointestinal Issues
Santa Monica, California
This study is a randomized, double-blind, placebo-controlled study of N=40 adult men and women with occasional GI issues. This study to assess the effect of a novel dietary supplement on the gut microbiome, nutrient gaps, and tolerability.
Trial Details
Trial Status:Recruiting
Age:18 - 60
Key Eligibility Criteria
Disqualifiers:Chronic Illness, Extreme Diets, Pregnancy, Others
Must Not Be Taking:Opioids, Gut Supplements
40 Participants Needed
Probiotics for Alcoholic Liver Disease
Los Angeles, California
Background: Significant sex differences exist in regard to alcohol use disorder (AUD) and alcoholic liver disease (ALD). To date, no studies have examined the brain-gut-microbiome (BGM) axis (which is the relationship between the gut, brain, and the bacteria within the gut) and sex-differences in AUD and ALD.
Aims: 1) Demonstrate baseline sex differences in the microbiome and metatranscriptome of AUD and ALD and correlate those differences to severity, 2) determine if these baseline sex differences predicts abstinence or ALD related outcomes, and 3) show how altering the microbiome can decrease the severity of AUD and ALD in a sexdependent manner. Hypothesis: Our project is aimed to explore the hypothesis that sex-related differences of the BGM axis in AUD and ALD explains the variation in patient severity and outcome by sex, and that alterations of the BGM axis can decrease the severity of AUD and ALD in a sex-dependent manner.
Methods: A pilot randomized placebo (VSL#3 vs placebo) control trial will be performed in patients with AUD and ALD for 6 months. Questionnaire data, clinical labs, serum, and feces for shotgun metagenomics will be collected at baseline, 3-months, and 6-months.
Anticipated Results: Patients with severe AUD/ALD will have more microbes and microbial genes associated with inflammation. These differences will predict outcomes at 6-months and that changes of this baseline microbiome with VSL#3 will lead to more positive outcomes than placebo, with men having greater benefit from VSL#3 than women.
Implications and Future Studies: The discovery of the mechanisms underlying sex-related differences in AUD/ALD is needed for the development of personalized recommendations for prevention and treatment in men and women
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Cirrhosis, Pancreatitis, Inflammatory Bowel, Others
Must Not Be Taking:Antibiotics, Probiotics
80 Participants Needed
Nutritional Programs for Gastrointestinal Health
Bothell, Washington
US residents who have gastrointestinal issues sign the informed consent form and are screened and enrolled for this study. Participants who are enrolled complete a survey upon enrollment and are randomized into one of three arms. This study is direct to participant and will NOT utilize clinical sites.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:25 - 75
Key Eligibility Criteria
Disqualifiers:Pregnancy, IBD, Cancer Therapy, Others
Must Not Be Taking:Antibiotics, Investigational Drugs
150 Participants Needed
Xanthohumol for Healthy Subjects
Portland, Oregon
A pilot study to assess the safety and tolerability of oral xanthohumol in humans, to identify a biological signature of xanthohumol exposure, and to characterize the role of xanthohumol metabolism by intestinal microorganisms in that signature.
Trial Details
Trial Status:Active Not Recruiting
Age:21 - 50
Key Eligibility Criteria
Disqualifiers:Not Listed
30 Participants Needed
Gixam Device for Colorectal Cancer Screening
Portland, Oregon
In the United States, colorectal cancer ranks second to lung cancer as a cause of cancer death and is the third most commonly occurring cancer in both men and women. Colorectal cancer in most cases develops slowly over a period of years, starting with the growth of precancerous polyps on the colon or rectum wall. The slow development of colorectal cancer makes it possible to detect and prevent it entirely by the removal of the precancerous polyps with colonoscopy. To date, there is no screening test, other than colonoscopy, able to detect the precancerous polyps. Gixam is a camera that takes multiple pictures of your tongue and uses artificial intelligence software to predict the presence of precancerous polyps within your colon or rectum that may eventually become cancerous.
The device creates the prediction by comparing the images taken of your tongue with many other images of tongues from healthy patients and patients with a history of precancerous polyps. Patients who have been predicted by Gixam to have precancerous polyps may be more likely to complete colonoscopy at the interval recommended by their physician, potentially reducing the likelihood of developing colorectal cancer.
The purpose of this research study is to test the accuracy of the Gixam device in persons that have received a negative outcome on a Fecal Immunochemical Test (FIT). This study will compare this prediction to the actual findings of your scheduled standard care colonoscopy and allow researchers to evaluate and improve the Gixam system.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:45 - 85
Key Eligibility Criteria
Disqualifiers:Colorectal Cancer, Family History, IBD, Others
400 Participants Needed
Topical Medications for Healthy Subjects
Sacramento, California
The global aim of this study is to investigate how the human microbiome changes from baseline with commonly used topical medications such as topical antifungals, low to mid potency topical steroids and emollients.
The specific aims are as follows:
1. Investigate whether ketoconazole cream, a commonly used topical antifungal, causes alterations in the human skin microbiome with short-term use.
2. Investigate whether desonide 0.05 % ointment, a commonly used low potency topical steroid, alters the human microbiome with short-term use.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Key Eligibility Criteria
Disqualifiers:Atopic Dermatitis, Psoriasis, Seborrheic Dermatitis, Others
Must Not Be Taking:Antibiotics
24 Participants Needed
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We started Power when my dad was diagnosed with multiple myeloma, and I struggled to help him access the latest immunotherapy. Hopefully Power makes it simpler for you to explore promising new treatments, during what is probably a difficult time.
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Frequently Asked Questions
How much do Microbiome clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Microbiome clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Microbiome trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Microbiome is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Microbiome medical study?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Microbiome clinical trials?
Most recently, we added Probiotics for Gestational Diabetes, Ketone Ester for Microbiome Health and Iron Supplements for Iron Deficiency to the Power online platform.
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