Fecal Microbiota Transplantation for IBS

• Sponsor: Madhusudan (Madhu) Grover, MBBS (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05776914
• Collaborator: (none)
• Enrollment: 43
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 3.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Irritable Bowel Syndrome; Diarrhea	Biological: Donor Fecal Microbiota Transplantation; Biological: Autologous Fecal Microbiota Transplantation	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 43 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of Proteolytic Activity-Guided Fecal Microbiota Transplantation for Irritable Bowel Syndrome (PRAGMAT Trial)
• Anticipated Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Mar 1, 2024
• Anticipated Study Completion Date: Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Donor Fecal Microbiota Transplantation Group Subjects will receive a fecal microbiota transplantation (FMT) using stool from a donor	Biological: Donor Fecal Microbiota Transplantation; Single fecal microbiota transplantation using 50 gm of freeze-thawed donor stool
Placebo Comparator: Autologous Fecal Microbiota Transplantation Group Subjects will receive a fecal microbiota transplantation (FMT) using their own stool	Biological: Autologous Fecal Microbiota Transplantation; Single fecal microbiota transplantation using 50 gm of stool collected from the same individual

Outcome Measures

Primary Outcome Measures

1. Percentage of responders [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

Secondary Outcome Measures

1. Change in level of fecal proteolytic activity [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 [Baseline, 12 weeks]

   Measured by permeability testing

3. Number of weekly responders [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 [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 [12 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Minnesota	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Madhusudan (Madhu) Grover, MBBS

Investigators

• Principal Investigator: Madhusudan Grover, MBBS, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Madhusudan (Madhu) Grover, MBBS, Regulatory Sponsor and Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT05776914
• Other Study ID Numbers: 22-005385
• First Posted: Mar 20, 2023
• Last Update Posted: Mar 20, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Madhusudan (Madhu) Grover, MBBS, Regulatory Sponsor and Principal Investigator, Mayo Clinic: Post-infection irritable bowel syndrome with diarrheal; Post-infection irritable bowel syndrome with mixed symptoms
• Additional relevant MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea

Study Results

No Results Posted as of Mar 20, 2023