Fecal Microbiota Transplantation for IBS

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05776914
• Other study ID #: 22-005385
• Status: Recruiting
• Phase: Phase 2
• Start date: April 15, 2024
• Est. completion date: September 2025

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: Margaret Breen-Lyles
• Phone: 507-293-0237
• Email: Breen-Lyles.Margaret[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 post-infection irritable bowel syndrome (PI-IBS) and high proteolytic activity. Proteolytic activity is the breakdown of proteins into smaller polypeptides or amino acids.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 43
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Campylobacter PI-IBS defined by Rome III or 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 fundoplication, 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

Related Conditions & MeSH terms

• Diarrhea
• Irritable Bowel Syndrome
• Syndrome

Intervention

Biological:
• 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

Locations

Country	Name	City	State
United States	Mayo Clinic in Minnesota	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Madhusudan (Madhu) Grover, MBBS

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of responders	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.	12 weeks
Secondary	Change in level of fecal proteolytic activity	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.	Baseline, 12 weeks
Secondary	Changes in in vivo excretion of 2-24 hr lactulose excretion	Measured by permeability testing	Baseline, 12 weeks
Secondary	Number of weekly responders	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)	12 weeks
Secondary	Global Adequate Relief Questionnaire	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?"	12 weeks
Secondary	Alistipes putredinis proportion post-FMT	Number of subject to have the bacteria Alistipes putredinis in stool sample after fecal microbiota transplantation (FMT)	12 weeks