Clinical trials: Fecal Microbiota
Clostridium Difficile Infection, Infection
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS)
This is a prospective, multicenter, open-label Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least one recurrence of CDI after a primary episode and have completed at least one round of…
- Conditions
- Clostridium Difficile Infection, Infection, Communicable Diseases
- Trial name
- CD3-OLS (NCT03931941)
- Testing
- RBX2660
- Where
- 51 sites in United States, Canada
- Volunteers
- 793 people
- Sponsor
- Rebiotix Inc.
Irritable Bowel Syndrome
SH-DS01 on Fecal Metagenomic Stability
This is a randomized, double blind, Phase 1 study. There will be a 12-week comparison of the safety of DS-01 versus placebo with a secondary outcome measure of the efficacy in a cohort of 100 men or women with IBS with…
- Trial name
- NCT04598295
- Testing
- DS-01
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Beth Israel Deaconess Medical Center
Ulcerative Colitis
A Prospective Non-interventional Multicenter Study to Evaluate the Effectiveness of Adalimumab in Korean Patients With Ulcerative Colitis (UC) and Identify Potential Predictors of Clinical Response in Routine Clinical Practice
This is a prospective, single country, multi-center study in participants with ulcerative colitis (UC) treated with adalimumab. Up to 147 participants are enrolled at approximately 20 sites.
- Trial name
- EUREKA (NCT02499263)
- Where
- 19 sites in South Korea
- Volunteers
- 150 people
- Sponsor
- AbbVie
Recurrent Clostridium Difficile Infection, Primary Clostridium Difficile Infection
Primary or Recurrent Clostridioides Difficile Infection Treatment With Capsules of Lyophilised Faecal Microbiota vs Fidaxomicin
Patients with microbiota alterations developed after being exposed to antibiotics are especially susceptible to Clostridioides difficile infections (CDI).
- Trial name
- NCT05201079
- Testing
- MBK-01, Fidaxomicin
- Where
- 21 sites in Spain
- Volunteers
- 93 people
- Sponsor
- Mikrobiomik Healthcare Company S.L.
Clostridium Difficile Infection, C.Difficile Diarrhea
The GRAFT Study: Gut RecolonizAtion by Fecal Transplantation
The primary objective of this study is to compare the gut microbiota and clinical outcomes of oral FMT during antibiotic treatment, immediately following antibiotic treatment, and placebo.
- Conditions
- Clostridium Difficile Infection, C.Difficile Diarrhea, CDI
- Trial name
- GRAFT (NCT03621657)
- Testing
- Low Dose FMT Capsule DE, Single Dose FMT Capsule DE
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- University of Wisconsin, Madison
Non-Alcoholic Fatty Liver Disease, Obesity
Effects of Dietary Fructose on Gut Microbiota and Fecal Metabolites in Obese Men and Postmenopausal Women: A Pilot Study
Non alcoholic fatty liver disease (NAFLD) is the most common cause of abnormal liver function tests in the U.S. (Browning, et al., 2004), ranging from steatosis to end-stage liver disease.
- Trial name
- NCT03339245
- Testing
- Fructose Solution (75 Grams), Glucose Solution (75 grams)
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Rockefeller University
Inflammatory Bowel Diseases, Ulcerative Colitis
Fecal Microbiota Transplant (FMT) in Pediatric Active Ulcerative Colitis and Pediatric Active Crohn's Colitis
The primary aims of this phase I/II, randomized, placebo controlled study are the assessment of safety and tolerability of universal donor FMT compared to placebo in pediatric and young adult subjects (ages 5 years through 30…
- Conditions
- Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease
- Trial name
- NCT02330653
- Testing
- Fecal Microbiota Transplant (FMT)
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Stacy A. Kahn
Recurrent Clostridium Difficile Infection
Lyophilized Fecal Microbiota Transplantation for Recurrent Clostridioides Difficile Infection
The primary goal is to study participants with recurrent C. difficile infection (CDI) treated with lyophilized fecal microbiota transplantation (FMT). The safety, clinical response and relapse rate in patients will be assessed.
- Trial name
- NCT03834038
- Testing
- Lyophilized Fecal Microbiota Transplantation
- Where
- Canada
- Volunteers
- 158 people
- Sponsor
- Vancouver Island Health Authority
Clostridium Difficile Infection
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection
This study will evaluate efficacy and safety information about RBX2660 for the treatment of recurrent Clostridium difficile infection (CDI), and will compare the efficacy of one treatment with RBX2660 versus antibiotic-treated…
- Trial name
- NCT02589847
- Testing
- RBX2660, Standard of Care Antibiotics
- Where
- 30 sites in United States, Canada
- Volunteers
- 272 people
- Sponsor
- Rebiotix Inc.
Recurrent C. Difficile Infection
Dose Ranging Study of the Safety and Efficacy of Orally Administered Lyophilized Fecal Microbiota Product (PRIM-DJ2727) for the Treatment of Recurrent Clostridium Difficile Infection (CDI)
To establish optimal dosing of lyophilized Fecal microbiota transplantation (FMT) product in the treatment of recurrent C. difficile infection
- Trial name
- NCT03298048
- Testing
- Low fecal microbiota dose, Mid fecal microbiota dose, High fecal microbiota dose
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- The University of Texas Health Science Center, Houston
Relapsing Remitting Multiple Sclerosis
Fecal Microbiota Transplantation (FMT) of FMP30 in Relapsing-Remitting Multiple Sclerosis
In this Phase 1b open-label prospective clinical trial, patients with relapsing-remitting MS will undergo FMT of FMP30 (donor stool) via colonoscopy and immunological efficacy endpoints will be assessed at various time points.
- Trial name
- MS-BIOME (NCT03594487)
- Testing
- FMP30 Donor Stool, Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool, Observational Control
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Jeffrey Gelfand
Inflammatory Bowel Diseases, Clostridium Difficile Infection
ICON-2: FMT and Bezlotoxumab Compared to FMT and Placebo for Patients With IBD and CDI
This is a randomized controlled trial to assess the clinical and microbiological impacts of FMT in combination with Bezlotoxumab (bezlo) compared to FMT in combination with placebo in patients with both inflammatory bowel disease…
- Trial name
- ICON-2 (NCT03829475)
- Testing
- Bezlotoxumab, Fecal Microbiota Transplantation
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Brigham and Women's Hospital
Clostridium Difficile Infection Recurrence
Fecal Microbiota Transplantation for C. Difficile Infection in Solid Organ Transplant Recipients
The objective is to examine the effect of Fecal Microbiota Transplantation (FMT) compared with vancomycin for cure of recurrent C.
- Trial name
- NCT03617445
- Testing
- FMT oral capsule, Oral Vancomycin
- Where
- 5 sites in United States
- Volunteers
- 3 people
- Sponsor
- University of Wisconsin, Madison
C. Difficile
Fecal Microbiota Transplantation to Treat Recurrent C. Difficile Associated Diarrhea Via Retention Enema or Oral Route
The objective of the study is to investigate the safety of a frozen or lyophilized inoculum administered, respectively, by retention enema or capsules in patients with recurrent C. difficile associated diarrhea (RCDAD).
- Trial name
- NCT02449174
- Testing
- Frozen Microbiota, Lyophilized Microbiota
- Where
- United States
- Volunteers
- 69 people
- Sponsor
- The University of Texas Health Science Center, Houston
Recurrent Clostridium Difficile Infection
Microbiota Restoration Therapy for Recurrent Clostridium Difficile-associated Diarrhea
This study will assess the safety of a new biologic drug, RBX2660 (microbiota suspension) as a treatment for recurrent Clostridium difficile-associated diarrhea (CDAD), which is the primary symptom of recurrent Clostridium…
- Trial name
- PUNCH CD (NCT01925417)
- Testing
- RBX2660 (microbiota suspension)
- Where
- 13 sites in United States
- Volunteers
- 34 people
- Sponsor
- Rebiotix Inc.
Infection With Multi-drug Resistant Organisms
FMT for Multidrug Resistant Organism Reversal
This proposed protocol involves the use of the fecal microbiota transplantation (FMT) to suppress or reverse colonization with multidrug resistant organisms (MDRO) in subjects with recurrent MDRO infections due to organisms of…
- Trial name
- NCT02312986
- Testing
- Fecal microbiota transplantation (FMT)
- Volunteers
- 1 people
- Sponsor
- Washington University School of Medicine
Clostridial Infection, Dysbiosis
Safety and Efficacy of FMT in Individuals With One or More Recurrences of Clostridium Difficile Associated Disease (CDAD)
Multi-center, randomized, placebo controlled, partially blinded trial comparing the safety and efficacy of fecal microbiota transplantation versus placebo both delivered by rectal enema in subjects 18 years of age or older with…
- Conditions
- Clostridial Infection, Dysbiosis, Probiotic Therapy
- Trial name
- NCT03548051
- Testing
- Fecal Microbiota Transplantation (FMT), Saline
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Colic, Inflammation
Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Colic
This study will compare 2 currently marketed formulas in healthy full term babies: Nutramigen A+ (a hypoallergenic formula) and Nutramigen-Enflora (hypoallergenic formula with Lactobacillus GG (LGG)) during 3 months of formula…
- Trial name
- LGG (NCT01279265)
- Testing
- Nutramigen with Enflora, Nutramigen A+
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- The University of Texas Health Science Center, Houston
Recurrent C. Difficile Associated Diarrhea
Fresh, Frozen or Lyophilized Fecal Microbiota Transplantation for Multiple Recurrent C. Difficile Associated Diarrhea
The objective of the study is to investigate the efficacy of fresh, frozen or lyophilized fecal microbiota transplantation (FMT) via colonoscopy in patients with recurrent C. difficile associated diarrhea (RCDAD).
- Trial name
- NCT02318992
- Testing
- Fecal Microbiota
- Where
- United States
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- The University of Texas Health Science Center, Houston
Clostridium Difficile
Early FMT for C.Difficile
Clostridium difficile infection (CDI) has increased worldwide in both frequency and severity. It is the leading cause of hospital acquired infection in developed countries and has been associated with at least 14,000 deaths per…
- Trial name
- NCT02465463
- Testing
- Fecal microbiota transplant (FMT), flexible sigmoidoscopy
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Emory University