- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04201821
Fecal Microbial Transplantation for the Treatment of Fecal Incontinence in Women (FMT for FI)
December 4, 2023 updated by: University of Pennsylvania
Fecal Microbial Transplantation (FMT) For the Treatment of Fecal Incontinence in Women
Open label pilot study assessing FMT to treat fecal incontinence in women 50 years of age and older.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Uduak U Andy, MD
- Phone Number: 215-662-7366
- Email: uduakumoh.andy@pennmedicine.upenn.edu
Study Locations
-
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Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Hospital of the University of Pennsylvania
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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
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Women 50 years of age and older with self-reported fecal incontinence defined as:
- Uncontrolled bothersome loss of liquid or solid fecal material that occurs at least weekly over the last 3 months and
- Failure of response to conservative management using fiber, diet modification, supervised pelvic floor exercises
- Baseline St. Mark's score of greater than or equal to 12
- Intolerance, unwillingness or inadequate response to constipating medications
- Self-reported current negative colon cancer screening based on the 2016 US preventive Services Task Force recommendation (applies to participants age 50-75). N/A if participant is over 75
- Able and willing to sign the informed consent form and agree with study procedures
Exclusion Criteria:
- Known food allergy that could lead to anaphylaxis
- Contraindications to naso-gastric tube placement including:
- Recent mid-face trauma
- History basilar skull fracture
- Recent ENT surgery
- Known coagulation abnormalities
- Esophageal varices and/or esophageal strictures
- Untreated prolapse beyond the hymen
- History of Inflammatory Bowel Disease (does not include IBS)
- Unrepaired rectovaginal fistula/chronic 4th degree laceration
- Full thickness rectal prolapse
- History of congenital anorectal malformation
- History of bowel resection surgery for any indication
- Minor anal procedures within 6 months for treatment of accidental bowel leakage (ABL) (injection of bulking agent or radiofrequency energy) or ligation of hemorrhoids
- Prior pelvic or abdominal radiation
- Diagnosis of cancer of the descending colon or anus
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: FMT Administration
This is a single arm study in which all eligible participants will receive FMT.
|
Fecal microbial transplantation (FMT) is the infusion of intestinal microbiota from healthy donors.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine if fecal microbial transplantation leads to clinical improvement in refractory fecal incontinence in older women.
Time Frame: 84 days
|
Number of subjects that shows significant improvement at 4 weeks after FMT, and will be maintained at 12 weeks, relative to baseline using the St. Mark's Vaizey score, a measure of fecal incontinence severity.
|
84 days
|
Determine the safety of FMT administration via naso-gastric tube in older women with FI.
Time Frame: 6 months
|
Frequency of adverse events, serious adverse events, and adverse events of special interest (including allergic reaction and gastrointestinal symptoms).
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine if FMT leads to improved quality of life for subjects.
Time Frame: 84 days
|
Number of subjects that have an improved quality of life at 4 and 12 weeks, measured by the FIQL scale.
|
84 days
|
Determine if the effectiveness of microbial engraftment following fecal microbial transplantation is associated with the degree of clinical improvement.
Time Frame: 28 days
|
Concentration of Microbiota present at baseline vs at week 4 in subjects that demonstrate a significant improvement at 4 weeks after FMT, relative to baseline using the St. Mark's Vaizey score.
|
28 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine whether the baseline microbiota of the subject affects engraftment in fecal microbial transplantation for fecal incontinence.
Time Frame: 28 days
|
Concentration of microbiota at baseline vs concentration of microbiota at 4 weeks.
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Uduak U Andy, MD, University of Pennsylvania
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 (Actual)
January 14, 2021
Primary Completion (Actual)
January 18, 2023
Study Completion (Actual)
January 18, 2023
Study Registration Dates
First Submitted
December 13, 2019
First Submitted That Met QC Criteria
December 13, 2019
First Posted (Actual)
December 17, 2019
Study Record Updates
Last Update Posted (Estimated)
December 5, 2023
Last Update Submitted That Met QC Criteria
December 4, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB# 834196
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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