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OpenTrials
Completed

NCT Number: NCT02485522

Diet and Stool Metabolites in Fecal Incontinence

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.

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Key information

Conditions

Fecal Incontinence Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Stool butyrate levels

    Time frame: within 1 week of collection

  2. Pattern of dietary intake by indicator

    Time frame: 1 year

Secondary outcomes

  1. Stool levels of global metabolites

    Time frame: within 1 week of collection

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

Diet and Stool Metabolites in Women With Fecal Incontinence

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 30, 2015
Registry last updated
Apr 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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