Diet and Fecal Incontinence in Senior Women

Diet Modification Program for Senior Women With Fecal Incontinence

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.

Study Overview

• Status: Completed
• Conditions: Fecal Incontinence; Incontinence; Bowel Incontinence; Accidental Bowel Leakage
• Intervention / Treatment: Behavioral: Diet Modification Pilot Program (DPM)

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.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Age ≥ 65 years,
2. 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,
3. adequate mobility for independent toileting,
4. ability for independent completion of food symptom diary,
5. has some control of her diet and is able to make adjustments
6. able to read and communicate in English,
7. willing to give informed consent

Exclusion Criteria:

1. Currently receiving another treatment for FI
2. significant cognitive impairment at baseline
3. 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)
4. current bloody diarrhea,
5. current or past diagnosis of colorectal

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Diet Modification Pilot Program; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in FI Symptoms (Vaizey)	Changes in the participant's symptom severity will be assessed from baseline to study conclusion.	6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in stool metabolites	Change from baseline in levels of stool deoxycholic acid(DCA, µmol/g feces)	6 weeks

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: University of Alabama at Birmingham
• Investigators: Principal Investigator: Uduak U Andy, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: April 6, 2018
• First Submitted That Met QC Criteria: April 16, 2018
• First Posted (Actual): April 27, 2018

Study Record Updates

• Last Update Posted (Actual): January 25, 2021
• Last Update Submitted That Met QC Criteria: January 22, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: diet; Fecal Incontinence; FI; ABL
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Fecal Incontinence
• Other Study ID Numbers: 825518

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No