Lily A Arya1, Holly E Richter2, Eric Jelovsek3, Marie Gantz4, Sara Cichowski5, Halina Zyczynski6, Keisha Dyer7, Nazema Siddiqui8, Cassandra Carberry9, Corey Broeckling10, Casey Morrow11, Purna Kashyap12, Susie Meikle13. 1. Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, Pennsylvania. 2. Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama. 3. Obstetrics and Gynecology and Women's Health Institute, Center for Urogynecology and Reconstructive Pelvic Surgery, Cleveland Clinic, Cleveland, Ohio. 4. Social, Statistical and Environmental Sciences, RTI International, Research Triangle Park, North Carolina. 5. Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, University of New Mexico Health Sciences Center, Albuquerque, New Mexico. 6. Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics, Gynecology and Reproductive Sciences, Women's Center for Bladder and Pelvic Health, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. 7. Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Reproductive Medicine, UC San Diego Health System, San Diego, California. 8. Division of Urogynecology, Department of Obstetrics and Gynecology, Duke Medical Center, Durham, North Carolina. 9. Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, Alpert Medical School of Brown University, Providence, Rhode Island. 10. Colorado State University Proteomics and Metabolomics Facility, Fort Collins, Colorado. 11. Department of Microbiome Resources, University of Alabama, Birmingham, Alabama. 12. Division of Gastroenterology, Department of Internal Medicine, The Mayo Clinic, Rochester, Minnesota. 13. Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD for the Pelvic Floor Disorders Network, Rockville, Maryland.
Abstract
AIMS: This paper aims to report the rationale, design, and the specific methodology of an ongoing nested observational study that will determine the association of the metabolite and microbial composition of stool with fecal incontinence (FI). METHODS: Eligible cases are participants with FI enrolled in the Controlling Anal Incontinence in women by Performing Anal Exercises with Biofeedback or Loperamide (CAPABLe) trial, a Pelvic Floor Disorders Network trial across eight clinical centers in the United States. Women of similar age without FI in the last year served as controls. All subject collected stool samples at the baseline and 24-week visit at home using a standardized collection method. Samples were shipped to and stored at centralized laboratories. RESULTS: Specimen collection commenced December 2014 and was completed in May 2016. Fecal water and DNA has been extracted and is currently being analyzed by targeted metabolic profiling for stool metabolites and 16S rRNA gene sequencing for stool microbiota. CONCLUSIONS: This article describes the rationale and design of a study that could provide a paradigm shift for the treatment of FI in women.
AIMS: This paper aims to report the rationale, design, and the specific methodology of an ongoing nested observational study that will determine the association of the metabolite and microbial composition of stool with fecal incontinence (FI). METHODS: Eligible cases are participants with FI enrolled in the Controlling Anal Incontinence in women by Performing Anal Exercises with Biofeedback or Loperamide (CAPABLe) trial, a Pelvic Floor Disorders Network trial across eight clinical centers in the United States. Women of similar age without FI in the last year served as controls. All subject collected stool samples at the baseline and 24-week visit at home using a standardized collection method. Samples were shipped to and stored at centralized laboratories. RESULTS: Specimen collection commenced December 2014 and was completed in May 2016. Fecal water and DNA has been extracted and is currently being analyzed by targeted metabolic profiling for stool metabolites and 16S rRNA gene sequencing for stool microbiota. CONCLUSIONS: This article describes the rationale and design of a study that could provide a paradigm shift for the treatment of FI in women.
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