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174 Microbiome Trials near Miami, FL
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 PowerProbiotics + tVNS for Cognition Improvement
Coral Gables, Florida
This project uses a hybrid trial design to evaluate two biomedical interventions targeting the gut-brain axis. One intervention is portable Transcutaneous Vagus Nerve Stimulator, tVNS, that is hypothesized to stimulate the autonomic nervous system, resulting in decreased inflammation and improved cognition. The second intervention is a probiotic supplement intended to replace gut bacteria that are associated with dysbiosis in persons with HIV and alcohol consumption.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:35 - 70
Key Eligibility Criteria
Disqualifiers:Major Psychiatric Illness, Opioid Use, Others
Must Not Be Taking:Antibiotics, Probiotics
80 Participants Needed
MHS-1031 for Acid Reflux
Miami, Florida
This study will be conducted as a multi-center, randomized, double-blind, placebo-controlled trial to evaluate the effect of MHS-1031 on heartburn-free days in subjects with GERD-related heartburn symptoms.
Stay on current meds
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Cancer, Heart Disease, Diabetes, Others
Must Be Taking:PPIs
247 Participants Needed
Ca-Mg Butyrate for Gulf War Syndrome
Miami, Florida
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
Cognitive Behavioral Therapy for Depression in HIV
Miami, Florida
The purpose of this randomized controlled trial is to understand how a cognitive-behavioral treatment (a form of psychological treatment) for depression changes the gut microbiome (micro-organisms that regulate the health of the gut), immune system, and the brain functioning in people living with HIV.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Untreated Mental Illness, Pregnancy, Others
Must Be Taking:Antiretrovirals
150 Participants Needed
DASH Diet for Gut Health
Tampa, Florida
The study investigators will recruit a generally healthy sample of 112 black and white adults from Birmingham, AL to participate in a 28-day randomized, controlled feeding study. Participants will be randomized to receive either the DASH diet or a standard American diet. All meals will be provided by the study. Fecal samples will be collected at multiple time points before, during, and after the dietary intervention and will be analyzed using PCR to amplify the V4 region of the 16S rRNA gene and to sequence bases using the MiSeq platform. Sequenced data will then be analyzed using QIIME. The investigators hypothesize that participants receiving the DASH diet will have a greater increase in alpha diversity and greater changes in abundances of CRC-associated microbes than participants receiving the standard American diet. The investigators will also evaluate functional-level markers including bile acid and short chain fatty acid (SCFA) production and inflammatory markers. If the investigator's hypothesis is supported, they expect to see reduced production of secondary bile acids (e.g., deoxycholic acid), greater SCFA production (e.g, butyrate), and reduction in gut and systemic inflammation (e.g, calprotectin, IL-6) among participants receiving the DASH diet compared to the standard American diet. The investigator's findings will provide preliminary evidence for the DASH diet as an approach for cultivating a healthier gut microbiota across racially diverse populations. These findings can impact clinical, translational, and population-level approaches for modification of the gut microbiota to reduce risk of chronic diseases like CRC.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:19 - 65
Key Eligibility Criteria
Disqualifiers:GI Conditions, Smoking, Heavy Alcohol, Others
Must Not Be Taking:Antibiotics, Probiotics
112 Participants Needed
Antibiotics for Neonatal Infections
Tampa, Florida
The goal of the NANO trial is to study the longstanding clinical practice of empirically administering intravenous antibiotics to extremely low birthweight (ELBW) infants in the first days of life. In this 802-subject multicenter placebo-controlled randomized clinical trial, the hypothesis to be tested is that the incidence of adverse outcomes is higher in babies receiving empiric antibiotics (EA) in the first week of life compared to babies receiving placebo. The study targets a population of ELBW infants in whom the clinical decision to use or not use EA is currently most challenging -- infants that are clinically stable that did not have a known exposure to intraamniotic infection and were not born preterm for maternal indications. The primary outcome is the composite outcome of late-onset sepsis (LOS), necrotizing enterocolitis (NEC), or death during the index hospitalization. Secondary safety outcomes will include total antibiotic days, days to full enteral feedings, and common morbidities in preterm infants that have previously been linked to EA, e.g. retinopathy of prematurity and bronchopulmonary dysplasia. Weight and length z-score, and head circumference, are standard measures to be collected weekly by clinical team per a standardized protocol.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Age:23 - 4
Key Eligibility Criteria
Disqualifiers:Maternal Infection, Respiratory Insufficiency, Hemodynamic Instability, Major Congenital Anomalies, Others
Must Not Be Taking:Antibiotics
802 Participants Needed
Digital Health Coaching for Cancer Survivorship
Gainesville, Florida
This study intends to explore feasibility, acceptability, and outcomes related to the use of a digital health coaching intervention for individuals who have completed primary therapy for cancer. Up to 625 individuals with diverse cancer diagnoses will be enrolled across up to 8 clinical sites to participate in a randomized wait-list control study. Those in the intervention group will receive 6 months of digital coaching up front followed by 6 months of ongoing monitoring via patient reported and clinical outcomes, as well as wearable data. Those in the control group will be monitored via patient reported and clinical outcomes as well as wearable data for the first 6 months followed by 6 months of digital health coaching. Both groups will collect fecal microbiome samples at enrollment and month 6. The study aims to explore if and how digital health coaching may be used to enhance outcomes for individuals following completion of primary cancer therapy.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Cognitive Impairment, Neurologic, Musculoskeletal, Others
625 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
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
Watermelon for Obesity
Tallahassee, Florida
The goal of this clinical trial is to evaluate the effect of daily fresh watermelon consumption for 6-weeks on gut health, including microbiome diversity, gut barrier and immune function in young adults with overweight and obesity. The main questions it aims to answer are:
1. Will consuming fresh watermelon daily for 6-weeks will improve intestinal barrier health and increase microbiome diversity such as an increased population of beneficial 'probiotic' bacteria when compared to control participants consuming a low-fat snack?
2. Will consuming fresh watermelon daily for six-weeks will improve other health measures, including body-composition, blood pressure, blood vessel function, blood lipid profiles, and measures of inflammation, as compared to control participants consuming a low-fat snack for the same time period?
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 30
Key Eligibility Criteria
Disqualifiers:Tobacco, Marijuana, Cardiovascular, Gastrointestinal, Others
Must Not Be Taking:Antibiotics, Prebiotics, Probiotics, Postbiotics
36 Participants Needed
Greens-Based Supplement for Aging
Auburn, Alabama
The primary purpose of this study is to assess changes in epigenetic markers of aging and physiological parameters in overweight older adults consuming a mixed greens-based supplement over a 30-day period in a randomized crossover design.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Age:50 - 65
Key Eligibility Criteria
Disqualifiers:Not Listed
20 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
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
Wild Blueberries for High Blood Pressure
Atlanta, Georgia
The purpose of the study is to determine the effectiveness of wild blueberries on cardiovascular health, cognitive function, and gut microbiota composition in non-Hispanic Black and White adults with elevated blood pressure.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:45 - 65
Key Eligibility Criteria
Disqualifiers:Cancer, Cardiovascular, Neurological, Others
Must Not Be Taking:Insulin, Antibiotics, Anti-inflammatories, Others
80 Participants Needed
Aerobic Exercise for Breast Cancer Survivors
Birmingham, Alabama
This trial studies how exercise and a specific diet can change gut bacteria in breast cancer survivors to help reduce tiredness and improve health.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Metastatic Cancer, Unstable Angina, Schizophrenia, Others
Must Not Be Taking:Steroids, Antibiotics
126 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
Probiotics for Cardiovascular Health
Winston-Salem, North Carolina
Nitric Oxide (NO) is an important molecule that is produced naturally in the body and that helps maintain healthy blood flow. Low availability of NO contributes to many diseases while administration of NO is therapeutic.
In addition to being made naturally in the body, NO can be obtained through the diet via the Nitrate-Nitrite-NO cycle. Nitrate, which is abundant in green leafy vegetables and beetroot juice, is partially converted to nitrite by oral bacteria. The nitrate and nitrite are taken up into the blood and nitrite is converted into NO. Remaining nitrate in the blood is taken back up into the mouth by salivary glands and the cycle continues. Emerging studies suggest that the Nitrate-Nitrite-NO cycle may contribute to cardiovascular health. In addition, there have been many studies where dietary nitrate is given to increase NO and treat various conditions.
The current study rests on the premise that the quality of the oral microbiome plays a major role in the Nitrate-Nitrite-NO cycle and hence cardiovascular health and the efficacy of dietary nitrate interventions. Investigators have begun to identify oral bacterial species that are effective nitrite producers as well as though that are nitrite depleters (those that interfere with nitrite production from nitrate).
In laboratory experiments, certain bacterial species have been shown to block nitrate to nitrite conversion by other oral bacteria. These nitrite depleting species are found in a commercially available oral probiotic designed to improve oral health. The purpose of this study is to examine if use of the probiotic negatively affects the Nitrate-Nitrite-NO cycle. Nitrate to Nitrite conversion will be assessed by measuring plasma levels of nitrite before and after consumption of nitrate-rich beetroot juice. Dietary nitrate to plasma nitrite conversion will assessed at baseline and after one week of consumption of the probiotic or a placebo (follow-up). The primary hypothesis of this study is that participants that consume the probiotic will have lower nitrate to nitrite conversion at follow-up compared to baseline and that there will be no significant change in nitrate to nitrite conversion between baseline and follow-up for participants who consume the placebo.
While this study does not aim to treat any specific disease, it is intended to elucidate a basic physiological function that may be relevant to cardiovascular health and certain NO-based therapeutics.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Autoimmune Diseases, Pregnancy, Others
Must Not Be Taking:Anticoagulants, Antiplatelets
20 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
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:Early Phase 1
Age:18 - 40
Sex:Female
Key Eligibility Criteria
Disqualifiers:Diabetes, Hepatitis, HIV, Others
Must Not Be Taking:Antibiotics, Immunosuppressives, Biologics, Chemotherapy
20 Participants Needed
Why Other Patients Applied
"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 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 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
"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
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
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
Vaginal Seeding for Cesarean-Delivered Infants
Falls Church, Virginia
Neonates delivered by scheduled Cesarean Section will be randomized to receive vaginal seeding (exposing the infant to Mother's vaginal flora) or sham. Infants will be followed for three years to examine health outcomes including microbiome development, immune development, metabolic outcomes, and any adverse events.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:0 - 50
Key Eligibility Criteria
Disqualifiers:Diabetes, Genital HSV, Group B Strep, Others
Must Not Be Taking:Antibiotics
600 Participants Needed
Aerobic Exercise for Gut Health
Washington D.C., 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
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
Fecal Microbiota Transplantation for Colitis
Bethesda, Maryland
This trial is testing if placing healthy bacteria from donor stool into the intestines of people with CGD and colitis can reduce inflammation. The target group is patients aged 10-60 who haven't responded to other treatments. The goal is to restore a healthy balance of gut bacteria to reduce inflammation. This method has shown promise in treating inflammatory bowel diseases like ulcerative colitis by restoring a healthy gut balance.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:10 - 60
Key Eligibility Criteria
Disqualifiers:Acute GI Infection, C Difficile, Others
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
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
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
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Frequently Asked Questions
How much do Microbiome clinical trials in Miami, FL 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 in Miami, FL 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 in Miami, FL 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 in Miami, FL 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 in Miami, FL 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 in Miami, FL?
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 in Miami, FL?
Most recently, we added Food Powder for Metabolism, Whole Food Plant-Based Smoothie for Knee Replacement and Yogurt Smoothies for Brain and Gut Health to the Power online platform.
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