Fecal Microbial Transplantation for the Treatment of Fecal Incontinence in Women

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

Detailed Description
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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.

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

Conditions
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Fecal Incontinence

Intervention / Treatment
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* Biological: fecal microbial transplantation (FMT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FMT Administration<br>This is a single arm study in which all eligible participants will receive FMT. | Biological: fecal microbial transplantation (FMT)<br>* Fecal microbial transplantation (FMT) is the infusion of intestinal microbiota from healthy donors.<br>|

What is the study measuring?
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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. | 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. | 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. | 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. | 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 |