RECRUITING

Fecal Microbiota Transplantation for IBS

Conditions

Irritable Bowel Syndrome Diarrhea Post-infection irritable bowel syndrome with diarrheal Post-infection irritable bowel syndrome with mixed symptoms

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-04-15

Study Completion:2025-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05776914

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.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion 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

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

Jonah Pedelty, MS

CONTACT

507-538-7774

pedelty.jonah@mayo.edu

Margaret Breen-Lyles

CONTACT

507-422-5759

breen-lyles.margaret@mayo.edu

Principal Investigator

Madhusudan Grover, MBBS

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Minnesota

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Madhusudan (Madhu) Grover, MBBS

Madhusudan Grover, MBBS, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-15

Study Completion Date2025-09

Study Record Updates

Study Start Date2024-04-15

Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Irritable Bowel Syndrome
Diarrhea