Diet and Stool Metabolites in Fecal Incontinence

Fecal Incontinence Clinical Trial

Official title:

Diet and Stool Metabolites in Women With Fecal Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02485522
• Other study ID #: 822653
• Status: Completed
• First received: June 26, 2015
• Last updated: April 13, 2018
• Start date: July 2015
• Est. completion date: June 2017

Study information

• Verified date: April 2018
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

Other:
• No Intervention
No intervention

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stool butyrate levels		within 1 week of collection
Primary	Pattern of dietary intake by indicator		1 year
Secondary	Stool levels of global metabolites		within 1 week of collection