search
Back to results

Fecal Microbiota Transplantation for IBS

Primary Purpose

Irritable Bowel Syndrome, Diarrhea

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Donor Fecal Microbiota Transplantation
Autologous Fecal Microbiota Transplantation
Sponsored by
Madhusudan (Madhu) Grover, MBBS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Post-infection irritable bowel syndrome with diarrheal, Post-infection irritable bowel syndrome with mixed symptoms

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic in Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Donor Fecal Microbiota Transplantation Group

Autologous Fecal Microbiota Transplantation Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Changes in in vivo excretion of 2-24 hr lactulose excretion
Measured by permeability testing
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)
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?"
Alistipes putredinis proportion post-FMT
Number of subject to have the bacteria Alistipes putredinis in stool sample after fecal microbiota transplantation (FMT)

Full Information

First Posted
March 1, 2023
Last Updated
April 10, 2023
Sponsor
Madhusudan (Madhu) Grover, MBBS
search

1. Study Identification

Unique Protocol Identification Number
NCT05776914
Brief Title
Fecal Microbiota Transplantation for IBS
Official Title
Efficacy and Safety of Proteolytic Activity-Guided Fecal Microbiota Transplantation for Irritable Bowel Syndrome (PRAGMAT Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Madhusudan (Madhu) Grover, MBBS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome, Diarrhea
Keywords
Post-infection irritable bowel syndrome with diarrheal, Post-infection irritable bowel syndrome with mixed symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
43 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Donor Fecal Microbiota Transplantation Group
Arm Type
Experimental
Arm Description
Subjects will receive a fecal microbiota transplantation (FMT) using stool from a donor
Arm Title
Autologous Fecal Microbiota Transplantation Group
Arm Type
Placebo Comparator
Arm Description
Subjects will receive a fecal microbiota transplantation (FMT) using their own stool
Intervention Type
Biological
Intervention Name(s)
Donor Fecal Microbiota Transplantation
Intervention Description
Single fecal microbiota transplantation using 50 gm of freeze-thawed donor stool
Intervention Type
Biological
Intervention Name(s)
Autologous Fecal Microbiota Transplantation
Intervention Description
Single fecal microbiota transplantation using 50 gm of stool collected from the same individual
Primary Outcome Measure Information:
Title
Percentage of responders
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in level of fecal proteolytic activity
Description
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.
Time Frame
Baseline, 12 weeks
Title
Changes in in vivo excretion of 2-24 hr lactulose excretion
Description
Measured by permeability testing
Time Frame
Baseline, 12 weeks
Title
Number of weekly responders
Description
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)
Time Frame
12 weeks
Title
Global Adequate Relief Questionnaire
Description
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?"
Time Frame
12 weeks
Title
Alistipes putredinis proportion post-FMT
Description
Number of subject to have the bacteria Alistipes putredinis in stool sample after fecal microbiota transplantation (FMT)
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Margaret Breen-Lyles
Phone
507-293-0237
Email
Breen-Lyles.Margaret@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madhusudan Grover, MBBS
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Minnesota
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Fecal Microbiota Transplantation for IBS

We'll reach out to this number within 24 hrs