Fecal Microbial Transplantation for the Treatment of Fecal Incontinence in Women

NCT ID: NCT04201821

Last Updated: 2024-06-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-14
• Study Completion Date: 2023-01-18

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.

Conditions

Fecal Incontinence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FMT Administration

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

Group Type: EXPERIMENTAL

fecal microbial transplantation (FMT)

Intervention Type: BIOLOGICAL

Fecal microbial transplantation (FMT) is the infusion of intestinal microbiota from healthy donors.

Interventions

fecal microbial transplantation (FMT)

Fecal microbial transplantation (FMT) is the infusion of intestinal microbiota from healthy donors.

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Uduak U Andy, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB# 834196

Identifier Type: -

Identifier Source: org_study_id