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40 Gut Health Trials Near You
Power is an online platform that helps thousands of Gut Health 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 PowerSoluble Arabinoxylan + Rice Bran for Gut Health in Healthy Adults
West Lafayette, Indiana
The importance of the gut microbiota for general health has been recently elucidated, but little is known about the impact of different types of nutrients on the gut microbiota. The soluble fiber in cereal by-products, arabinoxylan (AX), is known to be beneficial for generally promoting gut health. However, it is unclear whether consuming rice bran (RB), the source of AX, is equally helpful or better than consuming the extracted form of AX. This study aims to reveal the potential benefit of insoluble cereal bran fiber ingredients by comparing the effect of soluble arabinoxylan fiber alone and the mostly insoluble rice bran fiber, containing arabinoxylan, on intestinal health and gut microbiota. A placebo (maltodextrin) will be used as a control, with no significant changes expected in this group for the evaluated outcomes.
Participants will:
* Consume two different fiber supplements (soluble arabinoxylan or stabilized rice bran) as well as a placebo (maltodextrin) for 3 weeks each, separated by a 2-week washout period.
* Provide blood and stool samples at six different time points.
* Complete a food and gastrointestinal symptom diary during the intervention periods.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18 - 45
Key Eligibility Criteria
Disqualifiers:Gastrointestinal Disorders, Weight-loss Diets, Others
Must Not Be Taking:Antibiotics, Gut Microbiota Supplements
25 Participants Needed
Inulin for Healthy Subjects
West Lafayette, Indiana
The main aim of this study is to investigate differences in rate, extent of change and persistence of the gut microbiota in healthy adult volunteers in response to native chicory inulin. Along with investigating the impact of native chicory on bowl habits, mood and appetite. The two main questions this study aims to answer:
* To what extent do differences exist in rate of change over time between individuals in gut microbiota response (Bifidobacterium growth) to native chicory inulin supplementation.
* To what extent do differences exist between individuals in persistence of the gut microbiota upon stopping supplementation.
The effects of native chicory inulin on gut microbiota response will be compared to a maltodextrin placebo to sure changes in gut microbiota result directly from chicory inulin supplementation.
Participants will firstly complete a one-week run-in phase to establish baseline data and will then be allocated to either native chicory inulin or maltodextrin supplementation for 6 weeks. Inulin will be delivered at 12 g/day split into 2 x 6g portions. Maltodextrin will be calorie matched at 6 g/day split into 2 x 3g portions. This will then be followed by a 6 week post-supplementation phase. Fecal and blood samples will be collected regularly throughout all phases for analysis of gut microbiota and compounds of interest. Participants will also record any changes in gastrointestinal sensation, bowel habits and mood in a diary. Changes in appetite sensation will also measured.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 45
Key Eligibility Criteria
Disqualifiers:FODMAP Sensitivity, Food Allergies, Antibiotics, Gastrointestinal Disease, Psychiatric Disorders, Others
52 Participants Needed
Berries for Inflammation
Chicago, Illinois
The primary objectives are to characterize changes in indices of systemic and gut inflammation, assess host- and microbial-derived metabolite pools, and describe and link functional metagenomics and metatranscriptomic alterations in the gut microbiome with metabolite and inflammatory outcomes after acute (24hr) and chronic (4 week) intake of anthocyanins and ellagitannins from strawberry and red raspberries compared to a control diet (negative control), FOS (positive control, non-polyphenol, carbohydrate-based fermentable fiber/pre-biotic), or combination diet (berry composite + FOS) in human participants with low-grade inflammation.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:20 - 60
Key Eligibility Criteria
Disqualifiers:Smoking, Cardiovascular Disease, Diabetes, Cancer, Others
Must Not Be Taking:Lipid-lowering, Anti-inflammatory, Probiotics, Others
105 Participants Needed
Mango Consumption for Obesity
Chicago, Illinois
The primary objective of this project is to provide new knowledge through a comprehensive set of analyses that investigate the complex interplay between regular mango intake, gut microbial structure/ function, mechanisms of inflammation and insulin sensitivity in over weight (OW)/obese (OB) human subjects with chronic low-grade inflammation.
Trial Details
Trial Status:Active Not Recruiting
Age:20 - 60
Key Eligibility Criteria
Disqualifiers:Not Listed
60 Participants Needed
Resistant Potato Starch for Gut Bacteria
Guelph, Ontario/ON
The goal of this clinical trial is to evaluate how taking Resistant Potato Starch affects the gut microbiota compared to a placebo, in healthy adults. Over a 4-week period, participants will provide stool samples for analysis to detect any changes in gut bacteria. They will also record daily information in a diary about their stool consistency, frequency, digestive symptoms, and overall quality of life.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Key Eligibility Criteria
Disqualifiers:Pregnancy, GI Disorders, Diabetes, Cancer, Others
74 Participants Needed
Tagatose for Impaired Glucose Tolerance
Toronto, Ontario
The primary objective of this clinical-trial is to determine, in subjects with impaired fasting glucose (IFG) and/or insulin resistance (IR), if tagatose meets the definition of a prebiotic, namely that consuming tagatose for 4 weeks selectively stimulates the selective growth of bacteria in the colon and is associated with a health benefit (oral glucose tolerance) when compared to consuming the control treatment (10g sucrose) for 4 weeks.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 50
Key Eligibility Criteria
Disqualifiers:Diabetes, IBS, IBD, Pregnancy, Others
Must Not Be Taking:Hypoglycemics, GLP-I Agonists, Steroids, Antipsychotics
55 Participants Needed
Synbiotic Supplement for Gut Health
Bethesda, Maryland
Background:
Human intestines are home to a complex gut flora, also called microbiome; this is a natural occurring community of bacteria, fungi, yeast, and viruses. Changes in the balances of the gut flora can lead to illnesses, such as diabetes, colorectal cancer, and inflammatory bowel diseases. Synbiotics are dietary supplements people take to maintain proper balances of their gut flora aiming to improve health.
Objective:
To find out if a synbiotic supplement can increase the type and amount of beneficial gut bacteria in healthy people as well as improve cardio-vascular protection markers. The supplement contains a natural sugar from human milk.
Eligibility:
Healthy people aged 18 years or older who eat a typical western diet. They must take no medications (with a few exceptions).
Design:
Participants will have 2 clinic visits.
The first visit will start with screening. They will have a blood test and wait around 2 hours for the results of the blood test. The test will determine if they are eligible for the study.
Eligible participants will have additional blood drawn during the screening visit. They will be given a kit to collect a stool sample at home with instructions. They may complete a 3-day food diary. They will meet with a nutritionist and a physician by phone, telehealth, or in person.
The supplement is a powder that is mixed with water or another noncarbonated drink. Participants will drink 2 doses per day. Each dose will be 1 hour before or after a meal.
The second visit will be about 8 weeks after the first. Participants may repeat the 3-day food diary and nutrition visit. The physical exam, blood tests, and stool sample will be repeated.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Early Phase 1
Key Eligibility Criteria
Disqualifiers:Pregnancy, Vegan, Chronic Diarrhea, Others
Must Not Be Taking:Prebiotics, Probiotics, Others
100 Participants Needed
Bismuth Subsalicylate for Gut Health in Healthy Adults
Bethesda, Maryland
Background:
Many kinds of good or normal bacteria live on your skin and inside your stomach and intestines (gut). These bacteria are important to your health. What you eat, where you live, and what medicines you take can affect the bacteria in your gut. Bismuth subsalicylate (BSS) is an ingredient in common medicines for mild diarrhea and stomach pain. Products that contain BSS include Pepto-Bismol, Kao-Tin, and Pink Bismuth. But how BSS affects the bacteria in a person s gut is not fully understood.
Objective:
To see how BSS affects gut bacteria in healthy people.
Eligibility:
Healthy people aged 18 to 50 years.
Design:
Participants will have 6 clinic visits in up to 18 weeks. Only 1 visit must be at the NIH clinic; others may be either in-person or remote.
BSS is a liquid taken by mouth. Participants will take a dose of BSS 4 times a day for 2 days. They will take the same amount of BSS as a person would take to treat diarrhea or related problems.
Stool samples will be collected at each study visit. For remote visits, participants will be given a collection kit; they will collect the sample at home and send it in.
Participants will take surveys at each visit. They will answer questions about their diet and health.
Participants may also provide optional samples of blood, saliva, and urine.
Participants may have up to 2 optional colonoscopies. A long tube will be inserted via the rectum to collect tissue samples from the intestine. Participants will be sedated or placed under anesthesia for the procedure.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 50
Key Eligibility Criteria
Disqualifiers:Pregnancy, GI Ulcers, Bleeding Disorder, Others
Must Not Be Taking:Antibiotics, Salicylates, Anticoagulants, Others
40 Participants Needed
Perinatal 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
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
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
Humanized Prebiotics for Gut Health
Chapel Hill, North Carolina
This study aims to establish the safety of a 15 g/day dose of pure prebiotics ß(1-4) galacto-oligosaccharides (GOS) and GOS enriched with N-Acetyl-D-lactosamine, a building block of gut glycoproteins and human milk oligosaccharides (LAcNac, humanized GOS, hGOS) in healthy adult individuals. The safety and tolerability of the dose and the biological signature of GOS and hGOS in healthy adults will be established through a pilot clinical trial to assess GOS and hGOS effects vs placebo on (i) gastrointestinal adverse effects as measured by the Gastrointestinal Symptom and Severity Checklist (GSSC), (ii) increased abundance of beneficial gut bacteria and restoration of the gut microbiome saccharolytic potential, (iii) modulation of biomarkers of inflammation and (iv) evaluation of intestinal barrier function.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18 - 55
Key Eligibility Criteria
Disqualifiers:Not Listed
49 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
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
Peanuts for Prediabetes
Atlanta, Georgia
The overall objective of this 13-month randomized crossover study is to seek evidence demonstrating that daily consumption of peanuts and peanut products improve cardiometabolic, cognitive, and intestinal health in a racially diverse prediabetes population.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:20 - 59
Key Eligibility Criteria
Disqualifiers:Cancer, Renal, Cardiovascular, Others
Must Not Be Taking:Insulin, Antidiabetics, Antibiotics, Anti-inflammatories
72 Participants Needed
Blueberries for Prediabetes
Atlanta, Georgia
The goal of this clinical trial is to determine the effectiveness of using a freeze-dried wild blueberry powder on cardiometabolic health, cognitive function, and gut microbiota composition in adult women with prediabetes.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:45 - 65
Sex:Female
Key Eligibility Criteria
Disqualifiers:Allergies To Berries, Cancer, Hypertension, Smoking, Others
Must Not Be Taking:Insulin, Antidiabetics, Antibiotics, Anti-inflammatories
30 Participants Needed
L-Phenylalanine for Gut Health
New York, New York
The purpose of this study is to explore how the dietary supplement L-Phenylalanine affects the production of the metabolite phenylpropionic acid (PPA) and changes fungal populations of the gut microbiome.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Early Phase 1
Key Eligibility Criteria
Disqualifiers:Gastrointestinal Conditions, Pregnancy, Others
Must Not Be Taking:Antibiotics, Antifungals, MOAI, Others
20 Participants Needed
Probiotic for Obesity
Storrs, Connecticut
This is a pilot research study to investigate the effects of a probiotic supplement (L. acidophilus, strain TW01) on substances found in the stool and bloodstream, gut bacteria composition, body composition, as well as any relationship of these substances with markers of inflammation. Lactobacillus acidophilus is commonly found in a variety of fermented foods, including yogurt, cheese, and kefir, due to its ability to produce lactic acid and other substances. This bacterium is generally well-tolerated in healthy individuals and has a longstanding history of safe use. The investigators are doing this pilot study to see if a particular probiotic, called L. acidophilus (strain TW01) and isolated from fermented coffee grounds, can make a positive difference in human gut and overall health. Specifically, the investigators want to look at how this probiotic affects certain substances in human stool and blood, the makeup of the bacteria in the gut, and aspects of body composition. The investigators are also interested in whether these changes relate to markers of inflammation, which can tell us more about their impact on overall health. This probiotic strain has been shown in other studies to be safe and well tolerated, and the investigators hope our research will help us better understand how it works and whether it might support health in humans.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Early Phase 1
Age:18 - 60
Key Eligibility Criteria
Disqualifiers:Immunodeficiency, Diabetes, Heart Disease, Others
Must Not Be Taking:GLP-1 Analogues, Anti-inflammatories, NSAIDs, Others
12 Participants Needed
Dietary Intervention for Healthy Habits and Diet
Needham, Massachusetts
The PREDICT 3 study will build on previous research in over 2,000 individuals to further refine machine learning models that predict individual responses to foods, with the aim of advancing precision nutrition science and individualized dietary advice. The study incorporates both standardized and controlled dietary intervention, for the purpose of testing postprandial responses to specific mixed meals, in addition to a free-living period with a dietary record for measuring responses to a large variety of meals consumed in a realistic context, where the role of external factors (e.g. exercise, sleep, time of day) on postprandial responses may be determined. For the first time this PREDICT study is built on top of a commercial product which will allow access to a much larger group of participants who are already collecting large amounts of data through digital and biochemical devices that can contribute to science.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Pregnancy, Recent Heart Attack, Others
250000 Participants Needed
Positive Psychology for Irritable Bowel Syndrome
Boston, Massachusetts
The purpose of this study is to examine the feasibility, acceptability, preliminary efficacy, and candidate gut-brain mechanisms of an optimized positive psychology (PP) intervention for patients with irritable bowel syndrome (IBS), entitled "WISH," compared to an educational control intervention.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Severe Psychiatric Illness, Cognitive Impairment, Others
50 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
"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
"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
"I've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."
ZS
Depression PatientAge: 51
"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
Lentils + Chickpeas for Imbalance of Microbes
Tallahassee, Florida
The primary goal of this research is to evaluate the effect of daily whole-cooked chickpea and lentil consumption for 8-weeks on gut health, including microbiome-metabolome arrays and gut epithelial/barrier function, in healthy young adults.
Secondary Objectives include:
* To examine the effect of daily whole-cooked chickpea and lentil consumption for 8-weeks on the measures of metabolic health and inflammation in healthy young adults.
* To determine the feasibility of healthy young adults to successfully incorporate and sustain the recommended daily intake of pulses into their diets for eight consecutive weeks
Research Interventions:
Participants will be asked to consume a normal diet supplemented daily with either A) whole-cooked canned lentils, or B) whole-cooked canned chickpeas. The control condition will be instructed to consume a normal diet while restricting all pulse intake throughout the study.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 30
Key Eligibility Criteria
Disqualifiers:Cardiovascular, Gastrointestinal, Neurological, Endocrine, Others
Must Not Be Taking:Antibiotics, Prebiotics, Probiotics, Others
60 Participants Needed
Peanut Butter for Imbalance of Microbes
Tallahassee, Florida
The goal of this is parallel arm, randomized clinical trial is to learn and understand the effect of daily smooth peanut butter consumption on gut and metabolic health of children age 6-13. The main objectives are:
Primary Objective: To determine the prebiotic effect of daily smooth peanut butter consumption for eight weeks on gut health, including microbiome-metabolome arrays, gut epithelial/barrier function, and gut transit time, in school-aged children.
Secondary Objective(s)
1. To determine the effect of daily smooth peanut butter consumption for eight weeks on metabolic and inflammatory health markers, and measures of sleep quality in school-aged children.
2. To determine the potential mechanisms and feasibility of incorporating peanut butter into the diets of school-aged children as part of healthy, personalized nutrition.
Research Intervention(s): Researchers compare two groups to see if there really is an effect of daily smooth peanut butter intake on gut and metabolic health. The two groups are:
1. The 1st condition (PB) includes a normal diet supplemented daily with personalized portion of smooth PB, sandwiched between two plain unsalted saltine crackers.
2. The 2nd condition (CTL) includes a normal diet supplemented daily with an isocaloric amount of a nut-free, vegetable oil-based chocolate spread, sandwiched between two plain unsalted saltine crackers.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:6 - 13
Key Eligibility Criteria
Disqualifiers:Food Allergies, Gastrointestinal Disease, Neurological, Endocrine, Others
Must Not Be Taking:Antibiotics, Prebiotics, Probiotics, Postbiotics
60 Participants Needed
Butyric Acid for Gut Improvement After Heart Surgery in Kids
Omaha, Nebraska
Butyric acid has been shown to promote gut health and improve the microbiome in multiple adult studies. In preliminary studies in older children with inflammatory bowel disease, butyric acid was shown to be safe. However, it's suitability for infants and young children with congenital heart disease (CHD) has yet to be determined.
This study will examine butyric acid supplementation in infants and children, ages 1 month to 3 years, with CHD who require cardiac surgery with cardiopulmonary bypass. Study goals include determining the safety and tolerability of butyric acid supplementation before cardiac surgery, and to identify changes in gut microbial communities, metabolic profile, and genetic markers intestinal function. Also, the study seeks to establish a reduction in inflammation (inflammatory signaling) after cardiopulmonary bypass (CPB) in participants receiving butyric acid.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1, 2
Age:1 - 3
Key Eligibility Criteria
Disqualifiers:Continuous Enteral Feeds, GI Pathology, Others
Must Not Be Taking:Antibiotics, Chemotherapy
105 Participants Needed
Egg Intake for Obesity
Quebec City, Quebec
The purpose of this research is to determine the effect of additional daily egg intake on metabolic phenotypes and metabolism in the context of obesity.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:30 - 65
Key Eligibility Criteria
Disqualifiers:Pregnancy, Breastfeeding, Smoking, Vegans, Others
Must Not Be Taking:Antibiotics, Prebiotics, Probiotics
20 Participants Needed
Butyrate and Polyphenols for Gut Health
Fort Lauderdale, Florida
The purpose of this study is the assess the effectiveness and safety of a Butyrate formulation and a Butyrate + Polyphenol formulation on gut health, permeability and associated symptoms
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:21 - 70
Key Eligibility Criteria
Disqualifiers:Gastrointestinal Disease, Cancer, Diabetes, Others
Must Not Be Taking:Proton Pump Inhibitors, Antibiotics
105 Participants Needed
Saskatoon Berry for Metabolism Enhancement
Winnipeg, Manitoba
Diabetes becomes epidemic in worldwide countries. Nine out of ten diabetic patients are type 2 diabetes (T2D). T2D is characterized by insulin resistance and obesity. Uncontrolled diabetes leads to serious consequences including heart attack, stroke, chronic renal failure, liver failure, blindness and low limb amputation. Most of hypoglycemic medications have side effects. Natural foods or nutraceuticals with hypoglycemic potential are expected to provide a safer management for diabetic patients. Saskatoon berry is a popular fruit in Canadian Prairie and Northern states in USA. Our recent studies demonstrated Saskatoon berry (SB) powder attenuated hyperglycemia, hyperlipidemia, insulin resistance, inflammation, liver steatosis and gut dysbiosis in diet-induced insulin resistant mice, a model for T2D. The results in anti-diabetic activities of SB powder have been supported by other groups in high fat fed rats. Our preliminary studies in 20 healthy subjects demonstrated that dried whole SB (40 g/day for 10 weeks) significantly reduced fasting plasma glucose, total and LDL-cholesterol, systolic blood pressure, and increased plasma glucagon-like peptide compared to baseline, which was associated with increased intake of total fiber and decreased intake of saturated fat. The changes in metabolic and vascular variables significantly correlated with the alterations in gut microbiota. The combination of findings suggest that Saskatoon berry is good candidate of prebiotic functional food as a supplemental remedy for reducing the risk for metabolic syndrome and preventing or managing T2D. The effect of Saskatoon berry and its products on metabolic disorders have not been studied in healthy human subjects. We propose to examine the effects of oral administration of freeze-dried whole SB on glucose metabolism, insulin resistance and gut microbiota in healthy subjects in a single arm, open labeled phase I clinical trial.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Myocardial Infarction, Stroke, Hypertension, Others
Must Not Be Taking:Hypoglycemics, Antihypertensives, Lipid-lowering, Antibiotics
20 Participants Needed
Beta-Hydroxybutyrate for Crohn's Disease
Austin, Texas
This clinical trial aims to understand the feasibility of patients taking ketone body supplement beta-hydroxybutyrate (BHB) for 4 weeks with a confirmed diagnosis of Crohn's disease and starting new therapy for active disease.
The main questions it aims to answer are:
* BHB supplementation will be feasible and acceptable to patients.
* BHB supplementation will be associated with a reduction in systemic inflammation.
* BHB supplementation will be associated with a reduction in pro-inflammatory bacterial colonies.
Participants will:
* Take 3 capsules x 3 times per day for 4 weeks.
* Document food consumption using a 24-hour food recall questionnaire.
* Provide blood and fecal samples twice, at the beginning of the study and the 4-week mark.
Researchers will compare the group taking the ketone body supplement and the group not taking the supplement to see if the supplement provides relief of symptoms suffered from Crohn's disease.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Ketogenic Diet, Intermittent Fasting, C. Difficile, Others
Must Not Be Taking:Antibiotics, Acid Suppressors, Probiotics
20 Participants Needed
Cold Water Immersion for Immune Function
Greeley, Colorado
The purpose of this clinical trial is to explore the effects of a 4 week cold-water immersion (CWI) intervention on measures of immune function, sleep quality, mental health and well-being, and muscular strength. The main questions it aims to answer are:
* Does a 4 week CWI intervention improve measures of immune function, sleep quality, mental health and well-being, and muscular strength?
* Are there any differences in these measures when comparing cold tubs versus cold showers?
Researchers will compare chronic use of cold tubs to cold showers to see if cold water immersion may improve overall immune health and well-being.
Participants will:
* Undergo 4 weeks of Cold Tub or Cold Shower interventions at a frequency of 3 times a week for 4 minutes, if placed in the CWI intervention groups
* Undergo testing measures at the two pre- and post- intervention time points, if placed in the healthy control group or the CWI intervention groups
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:18 - 45
Key Eligibility Criteria
Disqualifiers:Cardiovascular Disease, Diabetes, Cancer, Others
Must Not Be Taking:Anti-inflammatories
75 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
Fermented Dairy Protein for Digestive Health
Phoenix, Arizona
A positive impact of a fermented dairy protein with prebiotic fiber supplement on self-reported GI complaints and wellbeing has been suggested (Wardenaar et al. 2024). The following project aims to further investigate the impact of this supplements in athletes with and without GI complaints in two separate data collections.
Part I of the data collection aims to investigate the impact of this supplement vs. a placebo on carbohydrate malabsorption (as a potential cause for GI distress) in athletes that normally don't identify as having GI complaints (randomized double-blind cross over study design covering a total of 9 weeks, including a 3-week washout period).
Part II of the data collection aims to confirm the earlier found results in the previous study (Wardenaar et al. 2024) in a group athletes self-reporting GI complaints that will be randomized into an intervention group or a placebo group (randomized double-blind parallel study design covering a total of 3 weeks).
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 50
Key Eligibility Criteria
Disqualifiers:Smoking, Lactose Intolerance, GI Disorders, Others
Must Not Be Taking:Corticosteroids, NSAIDs, Antibiotics, Others
114 Participants Needed
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Frequently Asked Questions
How much do Gut Health 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 Gut Health 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 Gut Health 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 Gut Health 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 Gut Health 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 Gut Health clinical trials?
Most recently, we added Positive Psychology for Irritable Bowel Syndrome, Butyric Acid for Gut Improvement After Heart Surgery in Kids and Resistant Potato Starch for Gut Bacteria to the Power online platform.
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