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FMT as a Treatment for Severe Motility Disorder

NCT04373252 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2022-05-06

No results posted yet for this study

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

BIOLOGICAL

FMT Lower Delivery (FMP 30)

Participants will receive two fecal microbiota transplants via antegrade enema, one week apart.

Sponsors & Collaborators

  • OpenBiome

    collaborator INDUSTRY

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Andrea Bischoff, MD · University of Colorado, Denver

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-31
Primary Completion
2021-07-01
Completion
2021-07-01
FDA Drug
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04373252 on ClinicalTrials.gov