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Diet and Fecal Incontinence in Senior Women

Sponsor
University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT03510052
Collaborator
University of Alabama at Birmingham (Other)
55
Enrollment
1
Location
1
Arm
34
Actual Duration (Months)
1.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Diet Modification Pilot Program (DPM)
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
55 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Diet Modification Program for Senior Women With Fecal Incontinence
Actual Study Start Date :
Feb 1, 2018
Actual Primary Completion Date :
Dec 1, 2020
Actual Study Completion Date :
Dec 1, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in FI Symptoms (Vaizey) [6 weeks]

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

Other Outcome Measures

  1. Changes in stool metabolites [6 weeks]

    Change from baseline in levels of stool deoxycholic acid(DCA, µmol/g feces)

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • University of Pennsylvania
  • University of Alabama at Birmingham

Investigators

  • Principal Investigator: Uduak U Andy, MD, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT03510052
Other Study ID Numbers:
  • 825518
First Posted:
Apr 27, 2018
Last Update Posted:
Jan 25, 2021
Last Verified:
Jan 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Pennsylvania
diet
Fecal Incontinence
FI
ABL
Additional relevant MeSH terms:
Fecal Incontinence

Study Results

No Results Posted as of Jan 25, 2021