FMT for Patients With IBS With Fecal and Mucosal Microbiota Assessment

NCT03125564 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2024-08-22

No results posted yet for this study

Summary

Irritable bowel syndrome (IBS) is a common functional bowel disorder of the gastrointestinal tract affecting up to 20 percent of the adolescent and adult populations. It is characterised by abdominal pain, irregular bowel habits, altered stool consistencies and bloating, and is associated with impaired quality of life. IBS can be categorised into diarrhoea predominant type (IBS-D), constipation predominant type (IBS-C), and mixed type (IBS-M). Fecal microbiota transplantation (FMT) defined as infusion of feces from healthy donors to affected subjects has shown impressive results with high cure rates in patients with recurrent clostridium difficile infections. The investigators propose a randomised, placebo-controlled trial of FMT in patients with IBS.

Conditions

  • Irritable Bowel Syndrome
  • Fecal Microbiota Transplantation

Interventions

PROCEDURE

Fecal Microbiota Transplantation

Fecal microbiota transplantation

PROCEDURE

Sham

Infusion of sham

PROCEDURE

Fecal and Mucosal Microbiota Assessment

To assess the fecal and mucosal microbiota before and after Fecal Microbiota Transplantation

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Siew Ng, Prof. · Chinese University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-12
Primary Completion
2022-09-16
Completion
2023-12-16

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03125564 on ClinicalTrials.gov