Health TrialsbyHealthPanel

Fecal Microbiota Transplantation for IBS

ConditionsIrritable Bowel SyndromeDiarrhea
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorMadhusudan (Madhu) Grover, MBBS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Donor Fecal Microbiota Transplantation

    Biological/Vaccine

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

  • Autologous Fecal Microbiota Transplantation

    Biological/Vaccine

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

Treatment groups

43 Participants
are divided into 2 treatment groups
Group A: Donor Fecal Microbiota Transplantation GroupExperimental treatment 1 intervention
Group B: Autologous Fecal Microbiota Transplantation GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 weeks

Secondary outcomes

1

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.

Time frame
Baseline, 12 weeks
2

Changes in in vivo excretion of 2-24 hr lactulose excretion

Measured by permeability testing

Time frame
Baseline, 12 weeks
3

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)

Time frame
12 weeks
4

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?"

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Madhusudan (Madhu) Grover, MBBS

Lead sponsor

Mayo Clinic

Sponsor institution

Source ClinicalTrials.gov
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