CompletedNot Applicable

Diet and Stool Metabolites in Fecal Incontinence

United States28 participantsStarted 2015-07

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 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.

What they're measuring

Stool butyrate levels

Timeframe: within 1 week of collection

Pattern of dietary intake by indicator

Timeframe: 1 year

Trial details

NCT IDNCT02485522

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-02

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