Clinical trials: Fecal 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
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
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
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
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
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
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.
Dysbiosis, Antimicrobial Resistant Organism
Fecal Microbiota Transplantation for Treatment of Gastrointestinal Dysbiosis or Clearance of ARO
The objective of this study is to assess the efficacy of FMTs via rectal administration for 1) symptom improvement in individuals with a formal diagnosis of dysbiosis due to active inflammatory bowel disease or irritable bowel…
- Trial name
- FMTGID (NCT03834051)
- Testing
- Fecal Microbiota Transplantation
- Where
- Canada
- Volunteers
- 33 people
- Sponsor
- Vancouver Island Health Authority
Crohn's Disease
Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT)
The objective of this trial is to assess if Fecal Microbiota Therapy (FMT) can reduce the risk of endoscopic recurrence of Crohn's disease (CD) in patients after intestinal resection.
- Trial name
- FMT (NCT02417974)
- Testing
- Fecal Microbiota Transplant (FMT)
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Boston Medical Center
Ulcerative Colitis, Inflammatory Bowel Diseases
Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Dietary Fiber in Patients With Ulcerative Colitis
A double-blind, randomized, placebo-controlled clinical trial examining the efficacy and safety of Fecal Microbiota Transplantation (FMT) and high fiber supplementation in patients with active mild to moderate Ulcerative Colitis…
- Trial name
- MINDFUL (NCT03998488)
- Testing
- Fecal Microbiota Transplantation, Psyllium Husk Powder
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Weill Medical College of Cornell University
Inflammatory Bowel Diseases, Clostridium Difficile Infection
The ICON Study: Outcomes After FMT for Patients With IBD and CDI
In this study the investigators will evaluate patients with IBD and and at least 2 confirmed c.difficile infections who will be undergoing FMT.
- Trial name
- NCT03106844
- Testing
- Fecal Microbiota Transplantation
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Brigham and Women's Hospital
Enterocolitis Clostridium Difficile Recurrent
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection
This is the first prospective, multi-center, double-blinded, randomized controlled study of a microbiota suspension derived from intestinal microbes. Patients who have had at least two recurrences of C.
- Trial name
- PUNCHCD2 (NCT02299570)
- Testing
- RBX2660 (microbiota suspension)
- Where
- 21 sites in United States, Canada
- Volunteers
- 150 people
- Sponsor
- Rebiotix Inc.
Acute Myeloid Leukemia, Allogeneic Hematopoietic Cell Transplantation
A Study of FMT in Patients With AML Allo HSCT in Recipients
This is a randomized, double-blind, placebo-controlled clinical trial of Fecal Microbiota Transplant (FMT) in 2 independent cohorts (60 acute myeloid leukemia patients undergoing intensive chemotherapy and 60 Allo-HCT patients).
- Trial name
- NCT03678493
- Testing
- Fecal Microbiota Transplant (FMT)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Masonic Cancer Center, University of Minnesota
C. Difficile Infection, Cancer
Safety of Stool Transplant for Patients With Difficult to Treat C. Difficile Infection
The purpose of this study is to test the safety of FMT in patients with C. difficile and cancer. In previous other studies, FMT has been shown to cure C.
- Trial name
- NCT02770326
- Testing
- Fecal Microbiota Transplantation (FMT)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Clostridium Difficile
A Prospective Trial of Frozen-and-Thawed Fecal Microbiota Transplantation for Recurrent Clostridium Difficile Infection
The primary goal of this proposal is to study the outcome of patients with recurrent Clostridium Difficile Infection (CDI) treated with frozen Fecal Microbiota Transplantation (FMT) in an open-labelled controlled trial.
- Trial name
- NCT02394275
- Testing
- Fecal Microbiota Transplant
- Where
- 2 sites in Canada
- Volunteers
- 140 people
- Sponsor
- McMaster University
Clostridium Difficile Infection (CDI)
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)
This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study of a microbiota suspension of intestinal microbes.
- Trial name
- NCT03244644
- Testing
- RBX2660, Open label RBX2660 (only for confirmed CDI recurrence)
- Where
- 66 sites in United States, Canada
- Volunteers
- 320 people
- Sponsor
- Rebiotix Inc.