Diet and Stool Metabolites in Fecal Incontinence
1 other identifier
observational
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2015
CompletedFirst Posted
Study publicly available on registry
June 30, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedApril 17, 2018
April 1, 2018
1.6 years
June 26, 2015
April 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Stool butyrate levels
within 1 week of collection
Pattern of dietary intake by indicator
1 year
Secondary Outcomes (1)
Stool levels of global metabolites
within 1 week of collection
Study Arms (2)
Fecal incontinence
Women age \>18 years old with a diagnosis of fecal incontinence
Controls
Women age \>18 without a diangosis of fecal incontinence
Interventions
Eligibility Criteria
Women with fecal incontinence from an outpatient GYN clinic.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2015
First Posted
June 30, 2015
Study Start
July 1, 2015
Primary Completion
February 1, 2017
Study Completion
June 1, 2017
Last Updated
April 17, 2018
Record last verified: 2018-04