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Fecal Microbiota Transplantation for Irritable Bowel Syndrome

Fecal Microbiota Transplantation for Irritable Bowel Syndrome

Recruiting
18-75 years
All
Phase 2/3

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Overview

Fecal microbiota transplantation (FMT) is a strategy that infuses a fecal suspension containing a healthy donor's microbiota into a patient's gut to restore his/her intestinal microbiome. FMT has a higher cure rate than standard antibiotic treatment for recurrent Clostridium difficile infections,and shows promising results in Inflammatory bowel disease(IBD).However, few studies have evaluated whether FMT is effective to treat Irritable bowel syndrome(IBS).The investigators propose to determine the efficiency and safety of FMT in patients with Irritable bowel syndrome.

Description

The present clinical trial aims to re-establish a gut functionality state of intestinal flora through FMT as a therapy for Irritable bowel syndrome(IBS). We established a standard microbiota isolation from donated fresh stool in lab. Then the microbiota is transplanted to the whole colon through a tube. Patients from Guangzhou First People's Hospital in this study will be assigned to receive FMT at least two times according to associated guidelines and follow-up for at least six months. Questionnaires will be used to assess participants at study start and at study completion.

Eligibility

Inclusion Criteria:

To be considered eligible for enrolment into the study, subjects must:

  • Be able to give written informed consent.
  • Males and females aged \>18 and \<75
  • Have IBS as defined by the Rome IV criteria

Exclusion Criteria:

Subjects will be excluded from the study if they meet any of the below criteria:

  • pregnant or having a follow-up of less than 6 months;
  • unable to give informed consent;
  • suffering from other severe disease ,including liver and kidney failure, cancers, intestinal diseases, inflammatory bowel disease, C difficile infection;
  • unable to undergo endoscopy.

Study details
    Irritable Bowel Syndrome
    Fecal Microbiota Transplantation

NCT03613545

Guangzhou First People's Hospital

14 May 2026

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