Fecal Microbiota Transplantation in Patients With Irritable Bowel Syndrome

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome (IBS)
• Interventions: Other: Fecal transplantation

• Registration Number: NCT02092402
• Lead Sponsor: Örebro University, Sweden

Brief Summary

The purpose of this study is to investigate the effect of fecal microbiota transplantation (FMT) on the symptoms of irritable bowel syndrome (IBS) patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-03-17
• Study First Submitted QC: 2014-03-18
• Study First Posted: 2014-03-20
• Primary Completion: 2016-11
• Study Completion: 2019-06
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-27
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fecal transplantation (stool from donor)	Fecal transplantation	Allogeneic fecal transplantation (from donor)
Fecal transplantation of own stool	Fecal transplantation	Autologous fecal transplantation (own stool)

Primary Outcome Measures

Name	Time	Method
Effect of fecal microbiota transplantation on the symptoms of IBS patients using the IBS version of the gastrointestinal symptom rating scale (GSRS-IBS)	6 months

Secondary Outcome Measures

Name	Time	Method
Effect of fecal microbiota transplantation on the symptoms of IBS patients using the IBS - severity scoring system (IBS-SSS)	6 months
Effect of fecal microbiota transplantation on the general health of IBS patients using the SF-36 survey	6 months
Effect of fecal transplantation on IBS patients' composition of mucosal microbiota (HITChip analysis)	2 months
Effect of fecal transplantation on IBS patients' mucosal immune cell composition (lymphocyte fingerprinting using flow cytometry)	2 months
Effect of fecal microbiota transplantation on the symptoms of IBS patients using the health-related quality of life questionnaire for IBS patients (IBS-QOL)	6 months
Effect of fecal microbiota transplantation on the symptoms of IBS patients using the hospital and anxiety depression scale (HADS)	6 months
Effect of fecal transplantation on IBS patients' visceral perception (Pain scores on the visual analogue scale during barostat procedure)	2 months
Effect of fecal transplantation on IBS patients' composition of fecal microbiota (HITChip analysis)	6 months

Trial Locations

Locations (1)

University Hospital Örebro; 🇸🇪 Örebro, Sweden