Clinical trials: Microbiota
Recurrent C. Difficile Infection
A Trial of CP101 for the Prevention of Recurrent CDI (PRISM4)
This is a Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of the Efficacy, Safety, and Tolerability of a Single Oral Administration of CP101 for the Prevention of Recurrent Clostridioides difficile Infection (PRISM4).
- Trial name
- PRISM4 (NCT05153499)
- Testing
- CP101
- Where
- 68 sites in United States, Canada
- Volunteers
- 19 people
- Sponsor
- Finch Research and Development LLC.
Infectious Disease of Digestive Tract
Autologous Fecal Therapy
Ten healthy volunteers will be recruited to receive either an autologous stool transplant or a saline enema to determine if autologous fecal microbiota therapy will be able to rapidly, and safely, restore a patient's fecal…
- Trial name
- NCT02046525
- Testing
- Autologous fecal microbiota therapy
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Prader-Willi Syndrome, Obesity
Understanding the Role of Gut Microbiota in Hyperphagia in Prader-Willi Syndrome
This study aims to use a high-fiber supplementation, an intervention known to create shifts in the gut microbiota towards a healthier structure, to explore the relationship between gut microbiota, appetite control and feeding…
- Trial name
- PWSGUT (NCT05541003)
- Testing
- NBT-NM108
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Rutgers, The State University of New Jersey
Acute Pancreatitis, Intestinal Bacteria Flora Disturbance
Fecal Microbiota Transplantation for Pancreatitis
The intestinal microbiota plays a pivotal role in the maintenance of intestinal homeostasis and protecting the gut against pathogens by competing for nutrients, creating the intestinal biological barrier and modulating the host…
- Conditions
- Acute Pancreatitis, Intestinal Bacteria Flora Disturbance, Intestinal Dysfunction, Fecal Microbiota Transplantation
- Trial name
- FMTP (NCT02318134)
- Testing
- Fecal Microbiota Transplantation, normal saline
- Where
- China
- Volunteers
- 60 people
- Sponsor
- The First Affiliated Hospital of Nanchang University
Inflammation
Effects of Adding Chickpeas to the American Diet on Fecal Microbiota Composition and Markers of Inflammation
This prospective study will assess the effects of adding legumes, especially chick peas, to the diet of healthy adults on the commensal bacteria from feces of human subjects and resulting self-reported GI symptoms as well as…
- Trial name
- NCT02375347
- Testing
- Chickpea Enhanced Diet (Short term)
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- University of Florida
Infant, Very Low Birth Weight
Growth and Microbiome Development in Very Low Birth Weight Infants Fed Primarily Mother's Own Milk vs. Donor Human Milk
A study to compare growth, development of the intestinal bacterial environment, and other short term outcomes in groups of babies fed primarily their own mother's milk compared to those who receive primarily donor human milk.
- Trial name
- NCT02573779
- Testing
- Observational - no intervention
- Where
- 2 sites in United States
- Volunteers
- 125 people
- Sponsor
- Baylor College of Medicine
Irritable Bowel Syndrome
Fecal Microbiota Transplantation for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome
The objectives of this study are (1) to determine the efficacy of fecal microbiota transplantation (FMT), given as oral capsules, compared with placebo for the treatment of refractory diarrhea-predominant irritable bowel syndrome…
- Trial name
- NCT02328547
- Testing
- Fecal microbiota transplantation capsules
- Where
- 3 sites in United States
- Volunteers
- 48 people
- Sponsor
- Montefiore Medical Center
Irritable Bowel Syndrome
A Longitudinal Study to Identify IBS Phenotypes Using Fecal Microbiota and Hydrogen Breath Testing
Diarrhea-predominant irritable bowel syndrome (IBS-D) is a highly prevalent but poorly understood condition with limited treatment options.
- Trial name
- NCT03219528
- Testing
- Rifaximin 550 MG, Low FODMAP Diet
- Where
- United States
- Volunteers
- 74 people
- Sponsor
- University of Michigan
Pitt Hopkins Syndrome
MTT for Children With Both Pitt Hopkins Syndrome and Gastrointestinal Disorders
The investigators propose to investigate Microbiota Transfer Therapy (MTT) for treating patients with Pitt Hopkins Syndrome (PTHS) and gastrointestinal problems similar to Irritable Bowel Syndrome (IBS).
- Trial name
- NCT04132427
- Testing
- vancomycin, magnesium citrate, microbiota
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Arizona State University
Premature Intestinal Microbiota, Necrotizing Enterocolitis
Defining the Intestinal Microbiota in Premature Neonates
The investigators will collect daily faecal samples from premature (<32 weeks) infants in the intensive care unit from the day of birth until they are discharged.
- Conditions
- Premature Intestinal Microbiota, Necrotizing Enterocolitis, Late Onset Bloodstream Infection
- Trial name
- NCT01102738
- Where
- 3 sites in United Kingdom
- Volunteers
- 369 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Ulcerative Colitis
Golimumab Effect in the Modulation of Gut Microbiota in Ulcerative Colitis
This study aims to characterize the changes on intestinal microbiota pattern associated with the use of golimumab in order to determine if intestinal microbiota markers may correlate with golimumab therapeutic effect in patients…
- Trial name
- GOLI2015 (NCT03018925)
- Testing
- Golimumab
- Where
- Spain
- Volunteers
- 15 people
- Sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Microbiota, Anti-bacterial Agents
Healthy Patients & Effect of Antibiotics
The objective of this study is to evaluate the impact of antimicrobial (antibiotic) exposures on the microbiome in healthy adults, specifically during and after usual courses of the antimicrobials used to treat community acquired…
- Trial name
- NCT03098485
- Testing
- Levofloxacin, Azithromycin, Cefpodoxime
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Chronic Obstructive Pulmonary Disease
The Effect of Chlorhexidine on the Oral and Lung Microbiota in Chronic Obstructive Pulmonary Disease
Determine the effect of twice-daily chlorhexidine oral rinse on oral and lung microbiota biomass in subjects with chronic obstructive pulmonary disease (COPD) with chronic bronchitis.
- Trial name
- CLIMB (NCT02252588)
- Testing
- Chlorhexidine
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- University of Minnesota
Cirrhosis, Hepatic Encephalopathy
FMT in Cirrhosis and Hepatic Encephalopathy
Patients with end stage of liver disease or cirrhosis can develop confusion due to high ammonia and inflammation. This confusion is brought upon by changes in the bacteria in the bowels and may not respond to current standard of…
- Trial name
- NCT03796598
- Testing
- Fecal Microbial transplant Capsules, Fecal Microbial Transplant Enema
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- VA Office of Research and Development
PreDiabetes, Dysbiosis
Assessing Gut Microbiota Mediated Health Outcomes of Whole Wheat and Its Major Bioactive Components
This study will investigate the gut microbiota-mediated effects of whole wheat consumption on human health in adults with pre-diabetes.
- Conditions
- PreDiabetes, Dysbiosis, Endotoxemia, Inflammation
- Trial name
- NCT05318183
- Testing
- Whole Wheat Bread, White Bread (control)
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Ohio State University
Recurrent Clostridium Difficile Infection
Penn Microbiome Therapy for Recurrent Clostridium Difficile Infection
This is a randomized, open label, comparative, Phase II study to determine which dose of fecal microbiota transplant using Penn Microbiome Therapy (PMT) products is most effective in treating and preventing recurrence of…
- Trial name
- NCT03973697
- Testing
- Penn Microbiome Therapy - 001, Penn Microbiome Therapy - 002, Penn Microbiome Therapy - 003
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- University of Pennsylvania
Healthy Volunteers
Effects of S. Boulardii and Amoxicillin/Clavulanate on Gut Microbiota
The purpose of this study is to compare and contrast the effects of the probiotic Saccharomyces boulardii, the antibiotic amoxicillin/clavulanate and the combination on the gut microbiota of healthy volunteers.
- Trial name
- NCT01473368
- Testing
- Saccharomyces boulardii, Amoxicillin Clavulanate
- Where
- United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Beth Israel Deaconess Medical Center
Clostridium Difficile Infection Recurrence
Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff
Subjects with recurrent C. difficile infection will receive an oral dose of CP101 capsules one time in Treatment Group I or matching placebo one time in Treatment Group II.
- Trial name
- PRISM3 (NCT03110133)
- Testing
- Full Spectrum Microbiota
- Where
- 58 sites in United States, Canada
- Volunteers
- 206 people
- Sponsor
- Finch Research and Development LLC.
Mechanisms, Defense
The Effect of Concord Grape Polyphenol-soy Protein Isolate Complex (GP-SPI) on Gut Microbiota
The overall purpose of this study is to evaluate the effect of nutritional supplementation with a well-characterized preparation of Concord grape polyphenol-soy protein isolate (GP-SPI) on the composition of the gut microbiota.
- Trial name
- NCT04018066
- Testing
- GP-SPI
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Rutgers, The State University of New Jersey
Rheumatoid Arthritis, Psoriatic Arthritis
Role of Oral and Intestinal Microbiota in Rheumatoid Arthritis (RA)
Rheumatoid arthritis (RA) is an inflammatory form of arthritis that causes joint pain and damage. RA attacks the lining of the joints (synovium), causing swelling that can result in aching and throbbing, and eventually deformity.
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis, Periodontal Disease
- Trial name
- NCT01198509
- Testing
- doxycycline, vancomycin
- Where
- 2 sites in United States
- Volunteers
- 178 people, healthy volunteers welcome
- Sponsor
- NYU Langone Health