Fecal Microbial Transplantation for the Treatment of Fecal Incontinence in Women (FMT for FI)

University of Pennsylvania

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Fecal Incontinence

Treatments: Biological: fecal microbial transplantation (FMT)

Study type: Interventional

Funder types: Other

Identifiers

NCT04201821

IRB# 834196

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: Female

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

FMT Administration

Experimental group

Description:

This is a single arm study in which all eligible participants will receive FMT.

Treatment:

Biological: fecal microbial transplantation (FMT)