Fecal Microbial Transplantation for the Treatment of Fecal Incontinence in Women

Phase 1

Terminated

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

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
FMT Administration	fecal microbial transplantation (FMT)	This is a single arm study in which all eligible participants will receive FMT.

Primary Outcome Measures

Name	Time	Method
Count of Participants With Adverse Events.	6 months	Frequency of adverse events, serious adverse events, and adverse events of special interest (including allergic reaction and gastrointestinal symptoms).
Number of Subjects That Show 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	The St Marsk's Viazy score is a validated patient-reported instrument used to measure fecal incontinence severity. Score ranges from 0-24 with a decrease in the score representing an improvement. A subject has clinical improvement if they have demonstrated a sustained decrease of 4-5 points between the 4-week and 12-week measurements.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects That Have an Improved Quality of Life at 4 and 12 Weeks, Measured by the FIQL Scale.	84 days	The FIQL is a valid and reliable 29-item questionnaire designed to evaluate the impact of FI on four aspects (domains) of patients' quality of life: lifestyle; coping behavior; depression or self-perception; and level of embarrassment. Domain scores range from 1-4 (higher scores indicating better quality of life). An improvement in the score of 1 (one) within each domain would indicate an improvement in the quality of life.
Count of Participants That Demonstrate Microbial Engraftment Following Fecal Microbial Transplantation and Demonstrate Clinical Improvement.	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.

Locations (1): Hospital of the University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States