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NCT Number: NCT05776914

Fecal Microbiota Transplantation for IBS

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Diarrhea Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic in Minnesota

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Donor Fecal Microbiota Transplantation

Biological

Single fecal microbiota transplantation using 50 gm of freeze-thawed donor stool

Autologous Fecal Microbiota Transplantation

Biological

Single fecal microbiota transplantation using 50 gm of stool collected from the same individual

Primary outcomes

  1. Percentage of responders

    Time frame: 12 weeks

    Number of subjects receiving the donor fecal microbiota transplantation identified as a responder defined as a decrease of ≥50 points in Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) from baseline.

    The Irritable Bowel Syndrome Symptom Severity Score scale has a possible range of scores from 0-500. Mild cases are classified as a score of 75-175, moderate cases are classified as a score of 175-300, and severe cases are classified as a score of >300.

Secondary outcomes

  1. Change in level of fecal proteolytic activity

    Time frame: Baseline, 12 weeks

    The level of fecal proteolytic activity will be measured at baseline and again at 12 weeks. The proteolytic activity is measured using a standardized FITC Casein assay that relies on the activity of proteases in the sample to digest casein protein.

  2. Changes in in vivo excretion of 2-24 hr lactulose excretion

    Time frame: Baseline, 12 weeks

    Measured by permeability testing

  3. Number of weekly responders

    Time frame: 12 weeks

    Number of subjects to meet responder criteria of ≥30% decrease in average of worst abdominal pain in past 24 hours plus ≥50% decrease in the number of days per week with at least one stool that has a consistency of Type 6 or 7 (compared with baseline)

  4. Global Adequate Relief Questionnaire

    Time frame: 12 weeks

    Number of subjects to report adequate relief of IBS symptoms, measured by answering yes to question "In the past 7 days have you had adequate relief of your IBS symptoms?"

  5. Alistipes putredinis proportion post-FMT

    Time frame: 12 weeks

    Number of subject to have the bacteria Alistipes putredinis in stool sample after fecal microbiota transplantation (FMT)

Study contacts

Contact information is provided by the study sponsor or research team.

Jonah Pedelty, MS

CONTACT

[email protected]

507-538-7774

Margaret Breen-Lyles

CONTACT

[email protected]

507-422-5759

Sponsors and collaborators

Lead sponsor

Madhusudan (Madhu) Grover, MBBS

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 20, 2023
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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