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Diet and Stool Metabolites in Fecal Incontinence

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ClinicalTrials.gov Identifier: NCT02485522
Recruitment Status : Completed
First Posted : June 30, 2015
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment
Fecal Incontinence Other: No Intervention

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Study Type : Observational
Actual Enrollment : 28 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Diet and Stool Metabolites in Women With Fecal Incontinence
Study Start Date : July 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Group/Cohort Intervention/treatment
Fecal incontinence
Women age >18 years old with a diagnosis of fecal incontinence
Other: No Intervention
No intervention

Controls
Women age >18 without a diangosis of fecal incontinence
Other: No Intervention
No intervention




Primary Outcome Measures :
  1. Stool butyrate levels [ Time Frame: within 1 week of collection ]
  2. Pattern of dietary intake by indicator [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Stool levels of global metabolites [ Time Frame: within 1 week of collection ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women with fecal incontinence from an outpatient GYN clinic.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02485522


Locations
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United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02485522     History of Changes
Other Study ID Numbers: 822653
First Posted: June 30, 2015    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Keywords provided by University of Pennsylvania:
fecal incontinence
diet
nutrition
metabolites
stool
FI
Additional relevant MeSH terms:
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Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases