NCT03510052

Brief Summary

Investigators will conduct a single-arm pre-post intervention pilot study in 46 older women with Fecal Incontinence (FI), also known as Accidental Bowel Leakage (ABL). FI symptoms and stool metabolites will be measured at baseline. Intervention with the Diet Modification Program (DMP) will be administered. FI symptoms and stool metabolites will be measured after 6weeks of the intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 27, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 25, 2021

Status Verified

January 1, 2021

Enrollment Period

2.8 years

First QC Date

April 6, 2018

Last Update Submit

January 22, 2021

Conditions

Accidental Bowel LeakageFecal IncontinenceIncontinenceBowel Incontinence

Keywords

dietFecal IncontinenceFIABL

Outcome Measures

Primary Outcomes (1)

  • Change in FI Symptoms (Vaizey)

    Changes in the participant's symptom severity will be assessed from baseline to study conclusion.

    6 weeks

Other Outcomes (1)

  • Changes in stool metabolites

    6 weeks

Study Arms (1)

Diet Modification Pilot Program

OTHER

Investigator will administer DMP which will include a review of the booklets and any targeted recommendations based on the participant's food and symptom diary. The participant will follow the DMP for 6 weeks and report for a follow-up visit.

Behavioral: Diet Modification Pilot Program (DPM)

Interventions

Diet Modification Pilot Program (DPM)BEHAVIORAL

Investigator will administer DMP which will include a review of the booklets and any targeted recommendations based on the participant's food and symptom diary. The participant will follow the DMP for 6 weeks and report for a follow-up visit.

Diet Modification Pilot Program

Eligibility Criteria

Age65 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age ≥ 65 years,
  • FI defined as any uncontrolled loss of liquid or solid fecal material that occurs at least monthly over the last 3 months that is bothersome enough to desire treatment,
  • adequate mobility for independent toileting,
  • ability for independent completion of food symptom diary,
  • has some control of her diet and is able to make adjustments
  • able to read and communicate in English,
  • willing to give informed consent

You may not qualify if:

  • Currently receiving another treatment for FI
  • significant cognitive impairment at baseline
  • residence in a care facility that provides meals (participants who are not able to adjust their diet will be excluded because the intervention focuses on the participant, not their care facility)
  • current bloody diarrhea,
  • current or past diagnosis of colorectal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Uduak U Andy, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2018

First Posted

April 27, 2018

Study Start

February 1, 2018

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

January 25, 2021

Record last verified: 2021-01

Locations

US(1)