NCT03613545

Fecal Microbiota Transplantation for Irritable Bowel Syndrome

Efficacy and Safety of Fecal Microbiota Transplantation for Irritable Bowel Syndrome

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Guangzhou First People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Irritable Bowel Syndrome
• Fecal Microbiota Transplantation

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-08-10
• Primary completion: 2028-12-31
• Completion: 2030-12-31
• First posted: 2018-08-03
• Last updated: 2021-08-03

Locations

1 site across 1 country: China