NCT04373252

FMT as a Treatment for Severe Motility Disorder

Fecal Microbiota Transplant as a Treatment for Severe Motility Disorder

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 3 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Many patients that are treated with anorectal malformations are fecally incontinent for life. A Bowel Management Program has been developed to help these patients by creating a daily enema regimen to keep them artificially clean of stool in the underwear. Due to the high success rate of the program, many patients who suffer from fecal incontinence due to other reasons such as, spina bifida, sacrococcygeal teratoma and sacral agenesis are referred to the program. A new issue is emerging with a group of patients that no longer obtain effective results from their daily enemas, even though they have worked successfully for years. These same patients are presenting with a narrow, spastic left colon and remarkably dilated right colon. Our hypothesis is that prolonged enema administration negatively impacts the microbiota of the colon causing the lack of response from enema administration. The purpose of this study is to restore the normal flora of the colon by fecal microbiota transplant (FMT) which we believe will improve responsiveness to enemas. By restoring colonic flora, patients will again become responsive to daily enemas and regain successful bowel management.

Conditions

• Severe Motility Disorder

Interventions

Type	Name	Description
BIOLOGICAL	FMT Lower Delivery (FMP 30)	Participants will receive two fecal microbiota transplants via antegrade enema, one week apart.

Timeline

• Start date: 2021-07-01
• Primary completion: 2021-07-01
• Completion: 2021-07-01
• First posted: 2020-05-04
• Last updated: 2022-05-06

Regulatory

• FDA-regulated drug study