Fecal Microbial Transplantation for the Treatment of Fecal Incontinence in Women

NCT04201821 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: IRB# 834196
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fecal Incontinence

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  84 days

• Count of Participants With Adverse Events.

  Frequency of adverse events, serious adverse events, and adverse events of special interest (including allergic reaction and gastrointestinal symptoms).

  6 months

Secondary Outcomes (2)

• Number of Subjects That Have an Improved Quality of Life at 4 and 12 Weeks, Measured by the FIQL Scale.

  84 days

• Count of Participants That Demonstrate Microbial Engraftment Following Fecal Microbial Transplantation and Demonstrate Clinical Improvement.

  28 days

Other Outcomes (1)

• Count of Participants That Demonstrate Engraftment Following Fecal Microbial Transplantation.

  28 days

Study Arms (1)

FMT Administration

EXPERIMENTAL

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

Biological: fecal microbial transplantation (FMT)

Interventions

fecal microbial transplantation (FMT) BIOLOGICAL

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

FMT Administration

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Regulatory Lead
• Organization: University of Pennsylvania

psom-ind-ide@pobox.upenn.edu

215-662-4484

Study Officials

• Uduak U Andy, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2019
• First Posted: December 17, 2019
• Study Start: January 14, 2021
• Primary Completion: January 18, 2023
• Study Completion: January 18, 2023
• Last Updated: June 12, 2024
• Results First Posted: June 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)