NCT04201821

Fecal Microbial Transplantation for the Treatment of Fecal Incontinence in Women

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Fecal Incontinence

Interventions

Type	Name	Description
BIOLOGICAL	fecal microbial transplantation (FMT)	Fecal microbial transplantation (FMT) is the infusion of intestinal microbiota from healthy donors.

Timeline

• Start date: 2021-01-14
• Primary completion: 2023-01-18
• Completion: 2023-01-18
• First posted: 2019-12-17
• Last updated: 2024-06-12
• Results posted: 2024-06-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study