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Diet and Stool Metabolites in Fecal Incontinence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02485522
Recruitment Status : Completed
First Posted : June 30, 2015
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Tracking Information
First Submitted Date June 26, 2015
First Posted Date June 30, 2015
Last Update Posted Date April 18, 2018
Study Start Date July 2015
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 9, 2015)
  • Stool butyrate levels [ Time Frame: within 1 week of collection ]
  • Pattern of dietary intake by indicator [ Time Frame: 1 year ]
Original Primary Outcome Measures
 (submitted: June 29, 2015)
  • Stool butyrate levels [ Time Frame: within 1 week of collection ]
  • Pattern of dietary intake [ Time Frame: 1 year ]
Change History Complete list of historical versions of study NCT02485522 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 29, 2015)
Stool levels of global metabolites [ Time Frame: within 1 week of collection ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Diet and Stool Metabolites in Fecal Incontinence
Official Title Diet and Stool Metabolites in Women With Fecal Incontinence
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Women with fecal incontinence from an outpatient GYN clinic.
Condition Fecal Incontinence
Intervention Other: No Intervention
No intervention
Study Groups/Cohorts
  • Fecal incontinence
    Women age >18 years old with a diagnosis of fecal incontinence
    Intervention: Other: No Intervention
  • Controls
    Women age >18 without a diangosis of fecal incontinence
    Intervention: Other: No Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 13, 2018)
28
Original Estimated Enrollment
 (submitted: June 29, 2015)
30
Actual Study Completion Date June 2017
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02485522
Other Study ID Numbers 822653
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Pennsylvania
Study Sponsor University of Pennsylvania
Collaborators Not Provided
Investigators Not Provided
PRS Account University of Pennsylvania
Verification Date April 2018