- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04373252
FMT as a Treatment for Severe Motility Disorder
May 4, 2022 updated by: University of Colorado, Denver
Fecal Microbiota Transplant as a Treatment for Severe Motility Disorder
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 50 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The study population to be enrolled in this study will include patients 18 years of age and older, with a Malone (appendicostomy) or with a cecostomy, that have received daily enemas for the treatment of fecal incontinence with prior good results for months to years. However, now these patients report not having an acceptable enema response (up to 4 hours for evacuation) despite numerous attempts to adjust the enema additives. The patients typically display a narrow, spastic left colon and a dilated right colon on contrast enema. A minimum of 10 adult subjects will be enrolled first and followed for safety and efficacy outcomes for at least one month. After the initial 10 adult subjects, there will be a pause in enrollment to allow for a formal review of the adult safety and efficacy data by the primary investigator. At this time a request will be made to open enrollment of this study up to the pediatric population as well as adults.
Exclusion Criteria:
- Any patient who does not meet the above criteria will be excluded from this study. Also excluded: pregnant women, women of child-bearing potential who are unwilling to use an effective form of contraception for 30 days after FMT, women who are breastfeeding, subjects with end stage liver disease or cirrhosis, subjects with a life expectancy of less than 6 months, subjects with an absolute neutrophil count <500 cells/µL and those with severe food allergies.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fecal Microbiota Transplant
All participants will receive two fecal microbiota transplants one week apart.
The transplant will occur via antegrade enema and the enema transplant material will be provided by OpenBiome, the product used is FMT Lower Delivery (FMP 30).
|
Participants will receive two fecal microbiota transplants via antegrade enema, one week apart.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patients become responsive to daily enema treatments again
Time Frame: 1 year
|
The primary outcome measure for this study will be the results reported in the daily journals which will identify if patients become responsive to enema treatments again (administration and complete evacuation within a one-hour period) and are able to remain clean in the underwear for 24 hours.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Microbiota Analysis
Time Frame: 10 days
|
A secondary outcome measure will come from the microbiota analysis done on the collected stool samples.
By comparing the microbiota before and after FMT we will be able to determine if, and how much, the fecal microbiota transplant altered the flora of the colon.
|
10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Andrea Bischoff, MD, University of Colorado, Denver
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 1, 2021
Primary Completion (Actual)
July 1, 2021
Study Completion (Actual)
July 1, 2021
Study Registration Dates
First Submitted
April 30, 2020
First Submitted That Met QC Criteria
April 30, 2020
First Posted (Actual)
May 4, 2020
Study Record Updates
Last Update Posted (Actual)
May 6, 2022
Last Update Submitted That Met QC Criteria
May 4, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-2327
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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