Diet and Fecal Incontinence in Senior Women
Primary Purpose
Accidental Bowel Leakage, Fecal Incontinence, Incontinence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diet Modification Pilot Program (DPM)
Sponsored by
About this trial
This is an interventional treatment trial for Accidental Bowel Leakage focused on measuring diet, Fecal Incontinence, FI, ABL
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Hospital of the University of Pennsylvania
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Diet Modification Pilot Program
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in FI Symptoms (Vaizey)
Changes in the participant's symptom severity will be assessed from baseline to study conclusion.
Secondary Outcome Measures
Full Information
NCT ID
NCT03510052
First Posted
April 6, 2018
Last Updated
January 22, 2021
Sponsor
University of Pennsylvania
Collaborators
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT03510052
Brief Title
Diet and Fecal Incontinence in Senior Women
Official Title
Diet Modification Program for Senior Women With Fecal Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
University of Alabama at Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Study Procedure: Visit Schedule
Visit 1(Baseline visit): Following consent, the study coordinator will obtain participant's demographic data including age, race/ethnicity, body mass index. Data on medical comorbidities, surgical history and medications known to be associated with FI will be collected. The participant's severity of FI will be measured using the St. Mark's Vaizey scale (Vaizey). The impact of FI on quality of life will be measured using the Fecal Incontinence Quality of Life scale (FIQL). The presence, type, and severity of other pelvic floor symptoms known to be associated with FI will be assessed using the Pelvic floor Distress Inventory- Short Form. Participants will be given a Food and Bowel Symptom diary and a stool collection kit at the conclusion of the visit.
Visit 2(Intervention visit): Stool sample will be collected by the study coordinator. Investigators will administer the DMP. Participants will be given the booklet outlining the DMP and investigators will review the participant's Food and Symptom diary and provide targeted recommendations. The participant will be given a second Food and Symptom diary and stool collection kit to return 6 weeks after the intervention start date.
Calls: Trained Nutritionists will call the participant between weeks 2 and 4 for three unannounced 24h diet recall. The 24-hour dietary recalls will be collected using Nutrition Data System for Research, a computer-based software application that facilitates the collection of recalls in a standardized fashion.
Visit 3 (Follow up visit): Post intervention stool samples and Food and Symptom diary will be collected. Questionnaires including the Vaizey, FIQL, Pelvic Floow Disability Index (PFDI), and Patient Global Index of Improvement (PGI-I) will be administered by the study coordinator. Participants will receive compensation for participating in the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Accidental Bowel Leakage, Fecal Incontinence, Incontinence, Bowel Incontinence
Keywords
diet, Fecal Incontinence, FI, ABL
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diet Modification Pilot Program
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Diet Modification Pilot Program (DPM)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in FI Symptoms (Vaizey)
Description
Changes in the participant's symptom severity will be assessed from baseline to study conclusion.
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Changes in stool metabolites
Description
Change from baseline in levels of stool deoxycholic acid(DCA, µmol/g feces)
Time Frame
6 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Learn more about this trial
Diet and Fecal Incontinence in Senior Women
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