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

Primary Purpose

Fecal Incontinence

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
fecal microbial transplantation (FMT)
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fecal Incontinence

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Hospital of the University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FMT Administration

Arm Description

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

Outcomes

Primary Outcome Measures

Determine if fecal microbial transplantation leads to clinical improvement in refractory fecal incontinence in older women.
Number of subjects that shows 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.
Determine the safety of FMT administration via naso-gastric tube in older women with FI.
Frequency of adverse events, serious adverse events, and adverse events of special interest (including allergic reaction and gastrointestinal symptoms).

Secondary Outcome Measures

Determine if FMT leads to improved quality of life for subjects.
Number of subjects that have an improved quality of life at 4 and 12 weeks, measured by the FIQL scale.
Determine if the effectiveness of microbial engraftment following fecal microbial transplantation is associated with the degree of 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.

Full Information

First Posted
December 13, 2019
Last Updated
June 6, 2023
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT04201821
Brief Title
Fecal Microbial Transplantation for the Treatment of Fecal Incontinence in Women
Acronym
FMT for FI
Official Title
Fecal Microbial Transplantation (FMT) For the Treatment of Fecal Incontinence in Women
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
Administrative reasons
Study Start Date
January 14, 2021 (Actual)
Primary Completion Date
January 18, 2023 (Actual)
Study Completion Date
January 18, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FMT Administration
Arm Type
Experimental
Arm Description
This is a single arm study in which all eligible participants will receive FMT.
Intervention Type
Biological
Intervention Name(s)
fecal microbial transplantation (FMT)
Intervention Description
Fecal microbial transplantation (FMT) is the infusion of intestinal microbiota from healthy donors.
Primary Outcome Measure Information:
Title
Determine if fecal microbial transplantation leads to clinical improvement in refractory fecal incontinence in older women.
Description
Number of subjects that shows 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.
Time Frame
84 days
Title
Determine the safety of FMT administration via naso-gastric tube in older women with FI.
Description
Frequency of adverse events, serious adverse events, and adverse events of special interest (including allergic reaction and gastrointestinal symptoms).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Determine if FMT leads to improved quality of life for subjects.
Description
Number of subjects that have an improved quality of life at 4 and 12 weeks, measured by the FIQL scale.
Time Frame
84 days
Title
Determine if the effectiveness of microbial engraftment following fecal microbial transplantation is associated with the degree of clinical improvement.
Description
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.
Time Frame
28 days
Other Pre-specified Outcome Measures:
Title
Determine whether the baseline microbiota of the subject affects engraftment in fecal microbial transplantation for fecal incontinence.
Description
Concentration of microbiota at baseline vs concentration of microbiota at 4 weeks.
Time Frame
28 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uduak U Andy, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Fecal Microbial Transplantation for the Treatment of Fecal Incontinence in Women

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