Fecal Microbiota Transplantation for IBS

Description

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.

Conditions

Irritable Bowel Syndrome, Diarrhea

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Study Overview

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Study Details

Study 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.

Efficacy and Safety of Proteolytic Activity-Guided Fecal Microbiota Transplantation for Irritable Bowel Syndrome (PRAGMAT Trial)

Fecal Microbiota Transplantation for IBS

Condition
Irritable Bowel Syndrome
Intervention / Treatment

-

Contacts and Locations

Rochester

Mayo Clinic in Minnesota, Rochester, Minnesota, United States, 55905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Madhusudan (Madhu) Grover, MBBS,

Madhusudan Grover, MBBS, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

2025-09