Recruiting
Phase 2

Fecal Microbiota Transplantation

Sponsor:

Madhusudan (Madhu) Grover, MBBS

Code:

NCT05776914

Conditions

Irritable Bowel Syndrome

Diarrhea

Eligibility Criteria

Sex: Female

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Donor Fecal Microbiota Transplantation

Autologous Fecal Microbiota Transplantation

Study Details

Brief summary:

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

Study ID

NCT05776914

Start date

Apr 15, 2024

Status verified date

May, 2026

Completion date

Jun 26, 2027

Anticipated

Primary completion date

Jun 26, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

43 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Donor Fecal Microbiota Transplantation Group

Subjects will receive a fecal microbiota transplantation (FMT) using stool from a donor

placebo comparator: Autologous Fecal Microbiota Transplantation Group

Subjects will receive a fecal microbiota transplantation (FMT) using their own stool

Interventions

Donor Fecal Microbiota Transplantation

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

Autologous Fecal Microbiota Transplantation

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

Primary outcome measure

  • Percentage of responders [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Jonah Pedelty, MS

507-538-7774pedelty.jonah@mayo.edu

Margaret Breen-Lyles

507-422-5759breen-lyles.margaret@mayo.edu

Locations

Mayo Clinic in Minnesota

Recruiting

Rochester, Minnesota, United States, 55905

More Information

Sponsor

Madhusudan (Madhu) Grover, MBBS

Last update posted

May 8, 2026

Last verified

May, 2026

Keywords

  • Post-infection irritable bowel syndrome with diarrheal
  • Post-infection irritable bowel syndrome with mixed symptoms

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Madhusudan (Madhu) Grover, MBBS on 2026-05-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.