Clinical trial NCT04201821: Fecal Microbial Transplantation for the Treatment of Fecal Incontinence in Women
Official title: Fecal Microbial Transplantation (FMT) For the Treatment of Fecal Incontinence in Women
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Fecal Incontinence
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2019-12-17
Enrollment: 10
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 84 days
measure: Count of Participants With Adverse Events.
timeFrame: 6 months
Secondary outcomes:
measure: Number of Subjects That Have an Improved Quality of Life at 4 and 12 Weeks, Measured by the FIQL Scale.
timeFrame: 84 days
measure: Count of Participants That Demonstrate Microbial Engraftment Following Fecal Microbial Transplantation and Demonstrate Clinical Improvement.
timeFrame: 28 days
Other outcomes:
measure: Count of Participants That Demonstrate Engraftment Following Fecal Microbial Transplantation.
timeFrame: 28 days
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Uduak U Andy, MD
role: PRINCIPAL_INVESTIGATOR
References: