RecruitingPhase 2Phase 3NCT03613545

Fecal Microbiota Transplantation for Irritable Bowel Syndrome

Efficacy and Safety of Fecal Microbiota Transplantation for Irritable Bowel Syndrome


Sponsor

Guangzhou First People's Hospital

Enrollment

120 participants

Start Date

Aug 10, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

  • 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 Criteria5

  • 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.

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Interventions

PROCEDUREfecal microbiota transplantation

200 mL of prepared fecal microbiota suspension from heathy donors' fresh feces was injected into the colon

PROCEDUREInfusion of sham

Infusion of sham

DRUGprobiotics, antibiotics or antidepressants

Drugs such as probiotics, antibiotics, antidepressants


Locations(1)

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

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NCT03613545


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