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Diet and Stool Metabolites in Fecal Incontinence

Diet and Stool Metabolites in Women With Fecal Incontinence

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02485522
Enrollment
28
Registered
2015-06-30
Start date
2015-07-31
Completion date
2017-06-30
Last updated
2018-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fecal Incontinence

Keywords

fecal incontinence, diet, nutrition, metabolites, stool, FI

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.

Interventions

OTHERNo Intervention

No intervention

Sponsors

University of Pennsylvania
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Stool butyrate levelswithin 1 week of collection
Pattern of dietary intake by indicator1 year

Secondary

MeasureTime frame
Stool levels of global metaboliteswithin 1 week of collection

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026