Fecal Microbiota Transplantation for IBS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Donor Fecal Microbiota Transplantation, Autologous Fecal Microbiota Transplantation.
- Who it may be relevant to
- Registry conditions: Irritable Bowel Syndrome, Diarrhea. Basic parameters: 18 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy and Safety of Proteolytic Activity-Guided Fecal Microbiota Transplantation for Irritable Bowel Syndrome (PRAGMAT Trial)
Overview
The purpose of this study is to learn the efficacy and safety of fecal microbiota transplantation (FMT) using stool from a donor with low proteolytic activity and containing the bacteria Alistipes putredinis in patients with irritable bowel syndrome (IBS) and high proteolytic activity. Proteolytic activity is the breakdown of proteins into smaller polypeptides or amino acids.
Interventions
- Biological Donor Fecal Microbiota Transplantation
Single fecal microbiota transplantation using 50 gm of freeze-thawed donor stool - Biological Autologous Fecal Microbiota Transplantation
Single fecal microbiota transplantation using 50 gm of stool collected from the same individual
Primary outcome measures
- Percentage of responders [Time frame: 12 weeks]
Secondary outcome measures (5)
- Change in level of fecal proteolytic activity [Time frame: Baseline, 12 weeks]
- Changes in in vivo excretion of 2-24 hr lactulose excretion [Time frame: Baseline, 12 weeks]
- Number of weekly responders [Time frame: 12 weeks]
- Global Adequate Relief Questionnaire [Time frame: 12 weeks]
- Alistipes putredinis proportion post-FMT [Time frame: 12 weeks]
Eligibility criteria
Inclusion criteria
- IBS defined by Rome IV criteria
- Non IBS-C
- Moderate to severe symptoms defined by IBS-SSS≥175
- Able to safely undergo and consent to colonoscopy
Exclusion criteria
- Immune deficiency or treatment with immunosuppressive medications
- Severe bowel or medical disease precluding administration of bowel prep
- Severe bowel or medical disease precluding colonoscopy with conscious sedation
- Active cancer
- Pregnant or lactating
- Abdominal surgery (exception of splenectomy, partial hepatectomy, partial/unilateral nephrectomy, laparoscopy, pelvic floor repair, mesh, liposuction, fundoplication, tubal ligation, gastric sleeve, oophorectomy, hernia, appendectomy, cholecystectomy, caesarean section and hysterectomy)
- Severe psychiatric disorder (HADS-A or D>16), or diagnosed alcohol or drug abuse disorder
- New probiotics or treatment with antibiotics, NSAIDs (within 4 wks prior to study entry)
- Use of treatments known to affect colonic motility (with exception of loperamide)
- Diagnosed h/o bleeding disorder
- Organic GI diseases (IBD, celiac disease, microscopic colitis)
- Chronic kidney or liver disease
- Absolute neutrophil count (ANC) <500 IU/ml
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mayo Clinic in Minnesota — Rochester
Identifiers
NCT: NCT05776914 · 22-005385