Fecal Microbiota Transplantation for Irritable Bowel Syndrome

Guangzhou First People's Hospital

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Irritable Bowel Syndrome; Fecal Microbiota Transplantation

Treatments: Procedure: Infusion of sham; Drug: probiotics, antibiotics or antidepressants; Procedure: fecal microbiota transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT03613545

K-2017-078-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups

fecal microbiota transplantation

Experimental group

Description:

fecal microbiota transplantation

Treatment:

Procedure: fecal microbiota transplantation

placebo fecal microbiota transplantation

Sham Comparator group

Description:

Infusion of sham

Treatment:

Procedure: Infusion of sham

Traditional treatments

Sham Comparator group

Description:

Traditional treatments according to associated guidelines such as probiotics, antibiotics or antidepressants

Treatment:

Drug: probiotics, antibiotics or antidepressants