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Recruiting NCT03613545

Fecal Microbiota Transplantation for Irritable Bowel Syndrome

Phase II / Phase III Interventional Irritable Bowel Syndrome Fecal Microbiota Transplantation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: fecal microbiota transplantation, Infusion of sham, probiotics, antibiotics or antidepressants.
Who it may be relevant to
Registry conditions: Irritable Bowel Syndrome, Fecal Microbiota Transplantation. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Efficacy and Safety of Fecal Microbiota Transplantation for Irritable Bowel Syndrome

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.

Detailed 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.

Interventions

  • Procedure fecal microbiota transplantation
    200 mL of prepared fecal microbiota suspension from heathy donors' fresh feces was injected into the colon
  • Procedure Infusion of sham
    Infusion of sham
  • Drug probiotics, antibiotics or antidepressants
    Drugs such as probiotics, antibiotics, antidepressants

Primary outcome measures

  • Change in Irritable Bowel Syndrome assessed by Symptom Severity Score (IBS-SSS) [Time frame: baseline; one month;three months;six months]
Secondary outcome measures (2)
  • Change in Irritable Bowel Syndrome assessed by Quality of Life (IBS-QOL) Questionnaire Scores [Time frame: baseline; one month;three months;six months]
  • Change in Depression and Anxiety assessed by Hamilton Depression Rating Scale (HAMD) and Hamilton Anxiety Rating Scale(HAMA) [Time frame: baseline; one month;three months;six months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Guangzhou First People's Hospital — Guangzhou

Publications

  • Distrutti E, Monaldi L, Ricci P, Fiorucci S. Gut microbiota role in irritable bowel syndrome: New therapeutic strategies. World J Gastroenterol. 2016 Feb 21;22(7):2219-41. doi: 10.3748/wjg.v22.i7.2219. PMID 26900286

Identifiers

NCT: NCT03613545 · K-2017-078-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗