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Efficacy and Safety Evaluation of Fecal Microbiota Transplantation in Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

Official title:
Efficacy and Safety Evaluation of Fecal Microbiota Transplantation in Irritable Bowel Syndrome

Clinical Trial Summary

Participants will be given FMT through oral capsules or nasojejunal tube once a month. After three-time treatment, participants were followed up for three months. Participants complete specific scales to assess improvement in symptoms, emotion and quality of life. Besides, they report adverse effects and collect fecal samples at each visit.

Clinical Trial Description

This prospective, single-arm interventional study aims to evaluate efficacy and safety of fecal microbiota transplantation in refractory IBS patients. Patients meeting the inclusion and exclusion criteria will provide written informed consent and receive FMT from healthy donors for three times. The administration methods include taking oral capsule or delivering microbiota suspension into the duodenum via nasojejunal tube. The patients receive treatment once a month and will be followed up for 3 months. Improvement in IBS symptoms, emotion and quality of life were assessed through IBS symptom severity scale (IBS-SSS), Gastrointestinal symptom rating scale (GSRS), IBS-Global Assessment of Improvement (IBS-GAI), Self-rating Anxiety Scale (SAS), Self-rating Depression Scale (SDS) and IBS-Quality of Life (IBS-QoL) respectively. Patients were asked to complete these scales and collect fecal samples at baseline, post-FMT and at 1, 2, 3 and 4 months after FMT. Primary endpoints were improvement in IBS-SSS score and global symptoms after three-time FMT. Secondary endpoints include Change in GSRS score, improvement in emotion and quality of life at post-FMT, 1 and 6 months, as well as change in fecal microbiota composition. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05740319
Study type Interventional
Source Shanghai Zhongshan Hospital
Contact Shengdi Wu
Phone (86)13817923359
Email wu.shengdi@zs-hospital.sh.cn
Status Recruiting
Phase N/A
Start date June 10, 2023
Completion date December 31, 2024
View Details
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