Diet and Stool Metabolites in Fecal Incontinence

NCT ID: NCT02485522

Last Updated: 2018-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-06-30

Brief Summary

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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

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Conditions

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Fecal Incontinence

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Fecal incontinence

Women age \>18 years old with a diagnosis of fecal incontinence

No Intervention

Intervention Type OTHER

No intervention

Controls

Women age \>18 without a diangosis of fecal incontinence

No Intervention

Intervention Type OTHER

No intervention

Interventions

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No Intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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822653

Identifier Type: -

Identifier Source: org_study_id

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