Fecal Microbial Transplantation for the Treatment of Fecal Incontinence in Women — FMT for FI  

Fecal Incontinence Clinical Trial

Official title: Fecal Microbial Transplantation (FMT) For the Treatment of Fecal Incontinence in Women

Status Terminated

Clinical Trial Summary

Open label pilot study assessing FMT to treat fecal incontinence in women 50 years of age and older.

Clinical Trial Description

Fecal incontinence, also known as accidental bowel leakage, is a common condition that is an immense burden to older women, caregivers, and the health care system. The overall goal of this study is to gather pilot data in order to conduct a future randomized controlled trial (RCT) for a novel treatment for fecal incontinence in older women utilizing fecal microbial transplantation (FMT). The investigator's hypothesis is that infusion of intestinal microbiota from healthy donors to older women with fecal incontinence will increase microbial diversity, reduce symptom severity, and improve quality of life. This study is a single arm, open-label clinical trial of FMT for the treatment of fecal incontinence refractory to conservative management. The investigators will measure the impact of FMT on change in symptom severity and quality of life and stool microbial diversity at 4 and 12 weeks after FMT. ;

Related Conditions & MeSH terms

• Fecal Incontinence

• NCT number: NCT04201821
• Study type: Interventional
• Source: University of Pennsylvania
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: January 14, 2021
• Completion date: January 18, 2023