Fecal Microbial Transplantation for the Treatment of Fecal Incontinence in Women

Fecal Incontinence Clinical Trial

— FMT for FI  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04201821
• Other study ID #: IRB# 834196
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: January 14, 2021
• Est. completion date: January 18, 2023

Study information

• Verified date: June 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: January 18, 2023
• Est. primary completion date: January 18, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

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

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

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

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Count of Participants That Demonstrate Engraftment Following Fecal Microbial Transplantation.	Concentration of microbiota at baseline vs concentration of microbiota at 4 weeks.	28 days
Primary	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
Primary	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	Number of Subjects That Have an Improved Quality of Life at 4 and 12 Weeks, Measured by the FIQL Scale.	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.	84 days
Secondary	Count of Participants That Demonstrate Microbial Engraftment Following Fecal Microbial Transplantation and Demonstrate Clinical Improvement.	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.	28 days