Diet and Stool Metabolites in Fecal Incontinence

Completed

• Conditions: Fecal Incontinence
• Interventions: Other: No Intervention

• Registration Number: NCT02485522
• Lead Sponsor: University of Pennsylvania

Brief Summary

Fecal Incontinence (FI) is a debilitating and common condition with a prevalence ranging from 7-15% in community dwelling women. FI has an immense impact on quality of life and is associated with increased care giver burden, increased rates of institutionalization, and significant cost burden in older women. Traditionally believed to be primarily caused by child birth injury, recent studies show that the typical age of onset of FI is age 40 which is remote from child birth. Treatment options for FI are limited because the mechanism underlying FI in older women are poorly understood. The overriding goal of this project is to investigate the relationship between diet, stool metabolites and fecal incontinence.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-26
• Study First Submitted QC: 2015-06-29
• Study First Posted: 2015-06-30
• Study Start: 2015-07
• Primary Completion: 2017-02
• Study Completion: 2017-06
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-13
• Last Update Posted: 2018-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

Inclusion Criteria

• Age greater than 18,
• parous women with fecal incontinence (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),
• current negative colon cancer screening

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Exclusion Criteria

• Current bloody diarrhea,
• current or past diagnosis of colorectal or anal malignancy,
• diagnosis of inflammatory bowel disease,
• recent antibiotic treatment,
• history of immune deficiency diseases,
• history of recent treatment with immune suppressant medications.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Controls	No Intervention	Women age \>18 without a diangosis of fecal incontinence
Fecal incontinence	No Intervention	Women age \>18 years old with a diagnosis of fecal incontinence

Primary Outcome Measures

Name	Time	Method
Stool butyrate levels	within 1 week of collection
Pattern of dietary intake by indicator	1 year

Secondary Outcome Measures

Name	Time	Method
Stool levels of global metabolites	within 1 week of collection

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States