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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 PowerPerinatal depression and anxiety (PDA) are the leading causes of maternal mortality in developed countries. Women with a history of depression have a 20 fold higher risk of PDA at subsequent pregnancies. The adverse outcomes extend beyond maternal well-being to long-term deficits in children and families. The gut-brain axis is a newly recognized key player in mental health disorders. Specifically, the microbial composition of the gut along with their metabolites are directly involved in disease onset and course. Recent clinical studies have identified diet as the most powerful environmental factor in manipulating gut microbiome. Given vulnerability and resistance of pregnant women to pharmacotherapy, particularly in those with a predisposition to mood disorders, as well as pregnant women's high motivation and commitment to improving gestational diet, a dietary/supplemental intervention to 'optimize' gut microbiome, is a favored approach in disease management. The study investigators aim to exploit microbial responsiveness to diet together with this maternal motivation, to alter the risk and severity of a universal public health concern that has dire and long-term consequences for new moms and their children.
The investigators of this trial, will first study the challenges in pursuing a study aimed at changing the microbiome of pregnant women with a history of mood disorders. Pregnant women in their second trimester will be recruited. Each will be assigned or randomized to one of four groups that will use a combination of diet, supplementation with probiotics, fish oil or no intervention. Each participant will meet with the study team virtually every 3 months until 1 year after delivery. At each study visit participants will be required to complete some questionnaires about their food intake, mood, and other health related measures and will provide a stool sample using the stool collection kits provided.
The findings from this study will help strategize for a larger study that will allow for comparison of the effects of diet, and/or supplementation with Omega-3 Fatty Acids (O3FA) and probiotics on the microbiome and the onset and severity of PDA.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:18 - 43
Sex:Female
Key Eligibility Criteria
Disqualifiers:Bipolar, Psychosis, Schizophrenia, Others
100 Participants Needed
MET-2 for Bacterial Blood Infections
Toronto, Ontario
ARO-DECAMP is a multi-centre, placebo-controlled, pilot and feasibility randomized controlled trial for the microbial consortium Microbial Ecosystem Therapeutic-2. Non-intensive care unit patients ≥ 18 years old diagnosed with a bloodstream infection and receiving treatment for an antibiotic resistant organism will be included. Participants will be randomized to receive either MET-2 or placebo for 10 days. Recruitment rate and study intervention adherence will be evaluated for feasibility. Participants will be followed for 180 days, and biological samples will be collected periodically for clinical, ecological, and biomarker outcomes.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Inflammatory Bowel Disease, Pregnancy, Others
Must Be Taking:Antibiotics
100 Participants Needed
Antibiotics Impact on Healthy Subjects
Bethesda, Maryland
More than 250 million courses of antibiotics are prescribed annually in the ambulatory care setting in the United States alone, including more than 40 million in children under 18 years of age. The perception that antibiotic use has minimal attendant adverse side effects contributes to the over-utilization of antibiotics in clinical circumstances when they are not strictly indicated. We have learned much about the human microbiome. The emerging view is of profound life-long bi-directional interactions between our microbiota and our cells. Perturbations in the microbiota affect metabolic, immune, and cognitive physiology in experimental animal models. When a person takes an antibiotic, the antibiotic diffuses via the blood into all body compartments, selecting for resistance. We propose to examine the effects of two commonly used antibiotics (the beta-lactam, amoxicillin and the macrolide azithromycin) on human microbial populations and on metabolic and immune physiology, studying healthy human volunteers in a randomized controlled clinical trial at the NIH Clinical Center. Our hypothesis is that in addition to acutely perturbing the human microbiome, these agents will have measurable metabolic and immunologic effects, with residual effects in the weeks that follow. To test this hypothesis, we will assess the effects of a brief therapeutic course of antibiotics on microbiome and metagenome composition. After an initial evaluation period, antibiotics will be given for 7 days or 5 days (depending on the antibiotic), and there will be a post-treatment evaluation. A control group will receive no drug intervention. Specimens will be obtained from multiple sites at each of 10 time points occurring before, during, and after antibiotic administration, and used for estimating bacterial and fungal composition and gene content. We will also assess the effects of the antibiotic course on markers of innate and adaptive immunity as well as markers of metabolic and hormonal physiology. A subgroup of subjects will be studied in the clinical center metabolic chamber to assess 24-hour energy expenditure and its components (sleeping, diet-induced, and activity energy expenditure), as well as macronutrient oxidation rates (carbohydrate, fat, and protein), during 3 of the 10 study visits. In addition to the primary data analyses, we will build a model that integrates the temporal data to begin to understand the complex intertwined physiology between microbiome and host.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1
Age:18 - 49
Key Eligibility Criteria
Disqualifiers:Obesity, Hypertension, Diabetes, Asthma, Others
Must Not Be Taking:Antibiotics, Corticosteroids, Immunosuppressants, Others
108 Participants Needed
Elemental Diet for Inflammatory Bowel Disease
Bethesda, Maryland
Background:
Bacteria that live inside the stomach and intestines are important for health. Chronic granulomatous disease (CGD) and inflammatory bowel disease (IBD) can make people have unhealthy bacteria. This can lead to gastrointestinal (GI) problems. Researchers want to see if people with CGD and IBD feel better when they change the bacteria in the stomach by following a special liquid diet.
Objective:
To see if an elemental diet can change the bacteria in the stomach and intestines of people with CGD and IBD. Also, to see if this helps GI symptoms.
Eligibility:
People ages 8-65 years with CGD, CGD-associated colitis, and IBD.
Design:
Participants will first be screened with:
Upper GI endoscopy and/or colonoscopy. A long, thin tube with a tiny camera at the end will be passed into the participant s body through the mouth or anus. Tissue will be collected. Participants will be sedated for the procedure. They will be sedated using a special mask or small plastic tube placed in an arm vein using a needle.
Participants will be put on the special diet for up to 4 weeks. They will stay in the hospital for up to 2 weeks. They will have check-ups. They will have blood, urine, and stool samples collected. They will keep a symptom diary to record how they feel and any GI symptoms.
Participants will have 2 follow-up visits. The first will be right after they finish the diet. The second will be 4 weeks later. They will have blood, urine, and stool samples collected. They will learn about re-introducing other foods into their diet.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 2
Age:8 - 65
Key Eligibility Criteria
Disqualifiers:Pregnancy, Active Infection, Others
Must Not Be Taking:Antibiotics
10 Participants Needed
Colchicine for Obesity and Insulin Resistance
Bethesda, Maryland
This trial is testing whether colchicine, a medication usually used for gout, can help improve metabolism in people with high body weight and inflammation. The study focuses on individuals aged 12 and older who have high insulin levels but not high blood sugar. Colchicine aims to reduce inflammation that contributes to insulin resistance and other health problems. Colchicine has been studied for its potential anti-diabetic properties, showing it can significantly reduce blood glucose levels.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:12 - 100
Key Eligibility Criteria
Disqualifiers:Heart Failure, CKD, Diabetes, Others
Must Not Be Taking:Colchicine, Anorexiants, Diabetic Meds, NSAIDs
500 Participants Needed
Sucralose for Healthy Subjects
Bethesda, Maryland
Background:
Artificial sweeteners like sucralose are found in many foods and drinks. Sucralose might affect hormones and cause health changes.
Objective:
To see if sucralose changes how medicines are absorbed and processed, how hormones are secreted, gut bacteria, and how fat cells are metabolized.
Eligibility:
People ages 18-60 who:
* Are black or Hispanic
* Weigh more than 110 pounds
* Have a body mass index of 25-40
* Do not have a condition that requires drug treatment
Design:
Participants will be screened with:
* Medical history
* Physical exam
* Blood, heart, and urine tests
Participants must not eat or drink anything with artificial sweeteners throughout the study.
Over 7 days, Participants will answer questions, and give daily urine samples and 1 stool sample. Participants will repeat these throughout the study.
Overnight Visit 1: participants will fast starting the night before. They will get breakfast at the visit. The visit includes:
* An IV will be placed in the arm. Participants will get 2 tablets of medicines. Blood will be drawn several times over 24 hours.
* A piece of fat tissue may be taken from the abdomen (biopsy).
* Participants will have a sweet drink. Blood samples will be taken over 2 hours.
Then participants will be randomly assigned to take either a sucralose capsule or placebo. They will take it twice a day for 2 weeks. They will complete two 24-hour food diaries.
Overnight Visit 2 repeats Visit 1 except the biopsy.
Then participants will take the capsules for another 2 weeks.
Overnight Visit 3 repeats Visit 1.
Participants may be contacted by phone within 4 weeks after they finish....
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 60
Sex:Female
Key Eligibility Criteria
Disqualifiers:Diabetes, Glaucoma, Cardiac Abnormalities, Others
Must Be Taking:Digoxin, Midazolam
150 Participants Needed
Aerobic Exercise for Gut Health
Washington, District of Columbia
This study aims to elucidate the differences in the gut microbiome functional activity and metabolome in adult premenopausal women with distinctive fitness levels and BMIs (with obesity, w/o obesity). The specific aims are as follows:
* Aim 1: To examine the effects of acute aerobic exercise at 60-70% heart rate reserve (HRRmax) for 30 minutes bout on changes in the abundance of SCFA-producing bacteria and their functional downstream metabolic activity.
* Aim 2: To examine the effects of acute aerobic exercise at 60-70% HRRmax 30-minute bout on changes in GM-released SCFA concentrations in stool and plasmatic metabolome.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:21 - 40
Sex:Female
Key Eligibility Criteria
Disqualifiers:Male, Pregnancy, Gastrointestinal, Endocrine, Others
Must Not Be Taking:Herbal, Fiber, Prebiotics, Antibiotics
40 Participants Needed
Metronidazole + Abiraterone + Dexamethasone for Prostate Cancer
Washington, District of Columbia
To determine if dexamethasone or dexamethasone plus metronidazole restore sensitivity to abiraterone for the treatment of metastatic prostate cancer.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Sex:Male
Key Eligibility Criteria
Disqualifiers:Infections, Liver Disease, Diabetes, Others
Must Be Taking:GnRH Analogues
58 Participants Needed
Vaginal Seeding for Cesarean Section Babies
Nashville, Tennessee
This is a single-center, parallel-arm, blind, sham-controlled, feasibility randomized controlled trial (RCT) to be conducted in healthy cesarean-born children. Eligible children will be randomized 1:1 to have their nose swabbed with either maternal vaginal secretions or a sterile swab (intervention vs. control group, respectively). The main hypothesis is that conducting an RCT assessing the utility of vaginal seeding in modifying the early-life upper respiratory tract (URT) microbiome of children born by cesarean section (C-section) is feasible and that the intervention is safe.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 40
Sex:Female
Key Eligibility Criteria
Disqualifiers:Diabetes, Hepatitis, HIV, Others
Must Not Be Taking:Antibiotics, Immunosuppressives, Biologics, Chemotherapy
20 Participants Needed
Apple Polyphenol Diet for Gut Health
College Park, Maryland
The goal of this controlled feeding trial is to learn about the metabolism of polyphenols, a common class of compounds found in plant-based foods, by the gut microbiome. It will evaluate how differences in gut bacteria across individuals influence metabolism of polyphenols from foods, which may influence health benefits that people receive from different foods.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 45
Key Eligibility Criteria
Disqualifiers:Pregnancy, Food Allergies, Renal, Others
Must Not Be Taking:Antacids, Antibiotics
30 Participants Needed
Probiotic + Prebiotic for Fatty Liver in HIV/AIDS
Nashville, Tennessee
Persons with human immunodeficiency virus (HIV) have higher risk of developing fatty liver disease (NAFLD) than HIV-negative persons but the reasons for this discrepancy are not known. Changes in the intestinal microbiome may contribute to the development of NAFLD in persons with HIV (PWH) through impairment of barrier function of the intestinal wall and by producing metabolites that are harmful to the liver. This project will test the hypothesis that HIV-related NAFLD is associated with differences in the intestinal microbiome and that supplementation with probiotic and prebiotic fiber will lead to improvements in markers of NAFLD in PWH.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Early Phase 1
Key Eligibility Criteria
Disqualifiers:Pregnancy, Celiac, Hepatitis C, Others
Must Be Taking:Antiretrovirals
63 Participants Needed
Probiotic Supplement for Heart Failure
Milwaukee, Wisconsin
The goal of this study is to determine the impact of 12 weeks of Lp299v supplementation (20 million cfu/day vs. placebo) on exercise capacity, circulating biomarkers of cardiac remodeling, quality of life, and vascular endothelial function in humans with heart failure and reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF) who have evidence of residual inflammation based on an elevated C-reactive protein level. This will be done in the setting of a randomized, double-blind, placebo-controlled trial.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:21 - 89
Key Eligibility Criteria
Disqualifiers:Severe Valve Disease, Cancer, Lung Disease, Others
Must Not Be Taking:Steroids, Anti-inflammatories, Antibiotics, Probiotics
20 Participants Needed
Probiotics for Vascular Aging
Milwaukee, Wisconsin
Emerging data suggest the gut microbiota regulates multiple mechanisms related to vascular aging, but no intervention targeting the gut microbiota has been tested in older adults without cardiovascular risk factors or cardiovascular disease. Early human data suggest an increase in potentially pathological gut metabolites such as trimethylamine-N-oxide (TMAO) are associated with older age, increased vascular stiffness, increased oxidative stress, and reduced nitric oxide (NO) bioavailability as evidenced by impaired endothelium-dependent vasodilation. Based on this data, the investigators hypothesize that supplementation with Lp299v will reverse human vascular aging in healthy older adults free of known traditional cardiovascular risk factors.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:50 - 99
Key Eligibility Criteria
Disqualifiers:Hypertension, Diabetes, High Cholesterol, Others
Must Not Be Taking:Hypertension, Dyslipidemia, Glucose Control
20 Participants Needed
Probiotics for Long COVID Symptoms
Milwaukee, Wisconsin
This trial tests whether taking a probiotic called Lp299v can help people who have long-term symptoms after COVID-19. The probiotic aims to reduce inflammation and improve blood vessel function. Adults aged 18-89 with these symptoms will take the supplement for a period of time to see if it helps. Probiotics have shown benefits in a variety of diseases, including respiratory infections, and may be beneficial in the adjunctive treatment of COVID-19.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Antibiotics, Chronic Diseases, Cognitive Impairment, Others
Must Not Be Taking:Vitamin K Antagonists
80 Participants Needed
Blueberries + Exercise for Cognitive Impairment
Kannapolis, North Carolina
This NIH project will examine the effects of routine flavonoid-rich blueberry intake (12-weeks), combined with or in the absence of regular moderate exercise, on cognitive function in a clinical population of older participants identified as experiencing age-related cognitive changes. This project's hypothesis is that the combination of flavonoid-rich diet and routine physical activity may potentiate cognitive benefits and reduce cognitive decline in an aging population, via mechanisms mediated by the gut microbiome.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:65 - 85
Key Eligibility Criteria
Disqualifiers:Diabetes, Uncontrolled Cardiovascular, Dementia, Others
Must Not Be Taking:Cognition Drugs
240 Participants Needed
Nasal Microbiota Transplant for Staphylococcus aureus Colonization
Baltimore, Maryland
This protocol aims to evaluate how NMT affects pediatric nasal microbiome diversity following intranasal mupirocin treatment
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1
Age:0 - 60
Key Eligibility Criteria
Disqualifiers:Immunodeficiency, Nasal Swab Issues, Others
Must Be Taking:Intranasal Mupirocin
175 Participants Needed
Nasal Bacteria Transfer for Neonatal Infections
Baltimore, Maryland
This study aims to determine whether a parent-to-child nasal microbiota transplant (NMT) can seed and engraft parental organisms into the neonatal microbiome and increase the neonatal microbiome diversity.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:0 - 60
Key Eligibility Criteria
Disqualifiers:S. Aureus Colonization, Immunodeficiency, Respiratory Illness, Others
175 Participants Needed
Nasal Microbiota Transplant for Preventing Newborn Infections
Baltimore, Maryland
This trial is testing if transferring healthy bacteria from a parent's nose to their newborn's nose can help protect the baby from harmful bacteria. The study focuses on newborns at Johns Hopkins Hospital. By creating a healthy bacterial environment in the baby's nose, the researchers hope to reduce the risk of infections.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1
Age:< 60
Key Eligibility Criteria
Disqualifiers:S. Aureus Colonization, Immunodeficiency, Respiratory Illness, Others
34 Participants Needed
Prebiotics for PTSD and Liver Cirrhosis
Richmond, Virginia
Despite medical advancements, PTSD remains a major issue in Veterans1. Current treatment strategies have relatively poor adherence. In patients with PTSD and cirrhosis, there is greater cognitive impairment as well as changes in gut microbiome structure and function2,3. In addition, when there is concomitant cirrhosis, medication-related treatment options become even narrower from a safety and tolerability perspective and cognitive issues pertaining to cirrhosis could impact participation3. Changes in gut microbiome in Veterans with cirrhosis and PTSD compared to those with cirrhosis without PTSD is characterized by a greater relative expression of pathobionts and reduction in stool microbiome diversity with reduction in bacteria that produce beneficial short chain fatty acids (SCFA)2. Modulation of the gut microbiome in patients with cirrhosis and PTSD may be an important therapeutic target. In prior studies with cirrhosis alone, microbial modulation using diet, antibiotics such as rifaximin, probiotics, and fecal microbiota transplant have improved gut microbial diversity and clinical outcomes in some cases4,5. In patients with cirrhosis without PTSD and in patients with PTSD without cirrhosis there is emerging evidence regarding prebiotics and other forms of gut microbial modulation.
Prebiotics are such an example6. Prebiotics are natural fibers derived from carbohydrates and can be beneficial to gut microbiota (good bacteria in the gut)6. Resistant starches (RS) are dietary fiber prebiotics found naturally in many foods including potatoes, plantains, and legumes6,7. In addition to being highly accessible, RS have been shown to be well tolerated with few adverse reactions. While no studies of RS exist in PTSD + cirrhosis patients, a meta-analysis of RS in IBD has shown RS to be an effective treatment in both animal and clinical studies where improvements in clinical remission and reduced mucosal damage were found7. However, there is insufficient data regarding patients with PTSD and cirrhosis regarding gut microbial structure and function modulation with dietary supplements such as resistant starches. These starches can improve SCFA production in elderly subjects, which could in turn affect the gut-brain axis favorably8.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Alcohol Abuse, Drug Use, Pregnancy, Others
Must Not Be Taking:Prebiotics, Probiotics, Antibiotics, Others
30 Participants Needed
Urolithin A for Healthy Adults
Baltimore, Maryland
Background:
As people age, the cells in the pancreas that produce insulin begin to release less of this hormone, and levels of blood glucose (sugar) rise. This can lead to illnesses such as diabetes. Urolithin A (UA) is a natural nutritional supplement that may improve how the body controls blood glucose.
Objective:
To learn if UA improves levels of insulin and other hormones that help control blood glucose.
Eligibility:
People aged 55 years and older with a body mass index of 27 or higher.
Design:
Participants will have 6 clinic visits over 8 weeks.
Participants will be screened. They will have a physical exam with blood and urine tests and a test of their heart function.
UA gelcaps are taken by mouth every morning at home. Half of participants will take UA. The other half will take a placebo. The placebo looks like the study drug but does not contain any medicine. Participants will not know which they are taking.
Participants will have tests during the study including:
Oral glucose tolerance: Participants will drink a sweet liquid. Blood will be drawn at intervals over the next 3 hours.
Continuous glucose monitor: A sensor with a needle that goes just under the skin will be placed on the upper arm. Participants will wear this sensor throughout the study.
Exercise. Participants will walk on a treadmill while their heart rate, hearth rhythm, and blood pressure are monitored. They will walk in a hallway at normal and fast paces.
Imaging scans of the thigh; scans of the brain are optional....
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:55 - 100
Key Eligibility Criteria
Disqualifiers:Diabetes, Autoimmune Disease, Cancer, Others
Must Not Be Taking:Glucose Lowering Drugs
180 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
Microbiome Analysis for Rosacea
Baltimore, Maryland
This trial examines how different antimicrobial treatments affect the skin and gut bacteria in people with moderate to severe rosacea. It aims to see if these treatments can help by changing the bacteria that live on the skin and in the gut.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Early Phase 1
Key Eligibility Criteria
Disqualifiers:Chronic Gastrointestinal Disease, Diabetes, Cardiac Disease, Immunodeficiency, Others
Must Not Be Taking:Antibiotics, Steroids, NSAIDs, Antacids
150 Participants Needed
Food Powder for Metabolism
Durham, North Carolina
This pilot study investigates the digestion rate of naturally occurring food DNA through the human digestive tract by detecting residual food DNA in stool samples. The investigators hypothesize that food DNA primarily transits through the digestive system within 24 hours, with maximal detection in stool samples collected the day after ingestion. Previous research has focused on food DNA digestion in human gastric juices, leaving digestion through the entire gut largely unexplored. This study employs a fixed-order within subjects design involving healthy participants. Each participant will submit a baseline stool sample, consume a single dose of a study-specific powdered food (reconstituted in water) differing from their usual diet, and provide the subsequent five stool samples. If five samples are collected in fewer than five days, an additional sample will be obtained on the fifth day post-consumption. The presence and decline of food specific DNA in these samples will be quantified using qPCR, enabling us to determine the digestion rate of food DNA. The study design poses with minimal risk as it non-invasively monitors the natural process of food DNA digestion and transit through stool sample analysis.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Irritable Bowel, Inflammatory Bowel, Diabetes, Others
20 Participants Needed
Whole Grains and Fruits for Obesity
Ithaca, New York
Dietary fiber has been shown to have beneficial effects on human health through its impact on microbes present in the gut. However, these effects can vary between individuals, and everyone may not reap the same health benefits by eating the same sources of fiber. Factors predicting how an individual's gut microbes as well as the beneficial metabolites produced by these microbes change in response to different sources of fiber would be helpful in developing precision nutrition approaches that maximize the benefits of dietary fiber. The objective of this study is to evaluate candidate predictors of gut microbiota response to fiber sources from either whole grains or fruits and vegetables.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:21 - 50
Key Eligibility Criteria
Disqualifiers:Electronic Implants, Untreated Thyroid, Immunosuppression, Gastrointestinal Disorders, Others
Must Not Be Taking:Antibiotics
15 Participants Needed
Vaginal Care System for Urinary Tract Infection
Newark, Delaware
Menopausal women have an increased risk of recurrent urinary tract infections. This is likely due in part to hormonal changes occurring during menopause. As estrogen falls, the vaginal microbiome shifts from a healthy one to a less healthy one. Because the vagina is close to the urethra, this vaginal microbiome shift contributes to a loss of protection against urinary tract infections (UTIs). The investigators are asking whether improving the vaginal microbiome using an over-the-counter vaginal hygiene system can reduce frequency of recurrent UTI in menopausal women.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:< 89
Sex:Female
Key Eligibility Criteria
Disqualifiers:Immunosuppressed, Allergies, Vaginal Infection, Others
40 Participants Needed
Resistant Potato Starch for Gulf War Syndrome
Madison, Wisconsin
Gulf War Illness (GWI) affects an estimated 25-32% of the over 700,000 coalition troops deployed to the Persian Gulf as part of the First Gulf War. GWI causes a range of pain, fatigue, gastrointestinal, skin, neurologic, and respiratory symptoms. New treatments to reduce GWI-associated morbidity are critically needed. Research suggests a role for the gastrointestinal microbiome in mediating health, including through impacting metabolism and immunity. The disruption of this microbiome plays a role in multiple diseases, and preliminary data suggest that Veterans with GWI have altered gut microbiota. The investigators will evaluate the effectiveness of a dietary fiber prebiotic supplement intervention on improving the quality of life of Veterans with GWI.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:45 - 80
Key Eligibility Criteria
Disqualifiers:COVID-19, Smoking, Alcohol Abuse, Others
Must Not Be Taking:Probiotics, Antibiotics, Immunomodulatory, Antacids
52 Participants Needed
Postbiotic for Exercise Performance
Saint Charles, Missouri
This is a prospective, randomized, placebo controlled, double-blind study to assess the effects of a postbiotic blend on exercise induced oxidative stress markers and exercise performance in healthy adult.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18 - 45
Key Eligibility Criteria
Disqualifiers:Diabetes, Heart Disease, Cancer, Others
Must Not Be Taking:Antibiotics, Probiotics, Statins, Hypertension
80 Participants Needed
Probiotics for Gut Microbiome Imbalance
Philadelphia, Pennsylvania
This study aims to evaluate whether probiotics can help maintain a healthy gut microbiome in patients receiving prophylactic antibiotics during elective orthopedic surgery. Antibiotics, while effective in preventing infections, can disrupt the balance of gut bacteria, leading to dysbiosis. The study hypothesizes that the use of probiotics during the perioperative period can prevent or reduce this disruption, supporting gut health and overall well-being. The research seeks to answer whether combining probiotics with routine antibiotic prophylaxis can preserve gut microbiome balance and improve patient outcomes.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 4
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Autoimmune, Chronic Intestinal, Others
Must Be Taking:Antibiotics
60 Participants Needed
Rosuvastatin and Gut Microbiome in Healthy Subjects
Philadelphia, Pennsylvania
There is evidence that the bacteria that naturally reside in the gut can influence how well we respond to medications. Therefore this study will look at how rosuvastatin, a medication used to lower cholesterol levels, may change the bacteria in the gut. Investigators will also examine how the gut bacteria will affect the ability of rosuvastatin to lower cholesterol levels. There will be 4 study visits over the course of about 16 weeks.The expected duration of the study is 2 years. Investigators plan to enroll 100 healthy volunteers during that time.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Cardiovascular Disease, Cancer, Diabetes, Others
Must Not Be Taking:Antihypertensives, Antibiotics, Probiotics, Others
62 Participants Needed
Diet Change for Metabolic Dysfunction in Colorectal Polyp Patients
Columbia, South Carolina
This study is a 6-month randomized controlled trail of diet modification designed to reduce chronic inflammation and reverse metabolic dysfunction among obese individuals with one or more polyps found at a colonoscopy screening. We also will recruit an at least overweight partner, who lives in the same household. To be eligible, participants will be apparently disease-free, obese AAs or EAs who have self-identified a partner who is at least 9 years, with whom they live and who also is at least overweight. Each index participant will: 1) Be AA or EA by self-report; 2) Be ≤55 years old; 3) Have undergone a colonoscopy screening and found to have ≥1 polyp(s); 4) Be free of co-morbid conditions or other factors that would limit participation in this trial; 5) Have a BMI ≥30kg/m2; 6) Be willing to commit to investing the time and effort required to participate in this trial (i.e., willing to complete all assessments and provide biological samples as specified in the consent); and 7) Have no recent antibiotic use. Their partner needs to: 1) Be at least 9 years old; 2) Live in the same household and consumes meals together; 3) Be at least overweight; 4) Agree to all study procedures, including provision of biological samples, body measurements, and self-reported dietary and other assessments; and 5) Have no recent antibiotic use.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:9 - 55
Key Eligibility Criteria
Disqualifiers:Comorbid Conditions, Others
Must Not Be Taking:Antibiotics
180 Participants Needed
Ca-Mg Butyrate for Gulf War Syndrome
Columbia, South Carolina
The primary objective of this clinical trial is to determine if treatment with Butyrate formulation that consists of butyric acid as calcium and magnesium derivatives (Ca-Mg Butyrate) improves the physical function of men and women Veterans suffering from Gulf War Illness (GWI). The primary outcome measure is a change from baseline on the Short Form Health Survey 36-item (VSF-36), with respect to physical functioning and symptoms. The secondary outcome will focus on the drug's role in (a) restoring gut microbiome and virome, (b) decreasing gastrointestinal disturbances (constipation, diarrhea, pain), (c) decreasing chronic fatigue, (d) decreasing systemic inflammation, and (e) a decrease in cognitive deficits.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:40 - 70
Key Eligibility Criteria
Disqualifiers:Schizophrenia, Bipolar, Organ Failure, Others
Must Not Be Taking:Steroids, Antibiotics, Immunosuppressives, Others
120 Participants Needed
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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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