Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, Pennsylvania.
Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama.
Neurourol Urodyn. 2018 Feb;37(2):634-641. doi: 10.1002/nau.23360. Epub 2017 Aug 1.
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).
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.
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.
This article describes the rationale and design of a study that could provide a paradigm shift for the treatment of FI in women.
本文旨在报告一项正在进行的嵌套观察性研究的原理、设计和具体方法,该研究旨在确定粪便代谢物和微生物组成与粪便失禁(FI)之间的关联。
符合条件的病例是参加 Controlling Anal Incontinence in women by Performing Anal Exercises with Biofeedback or Loperamide(CAPABLe)试验的 FI 患者,这是一个在美国 8 个临床中心进行的盆底功能障碍网络试验。过去一年中没有 FI 的年龄相似的女性作为对照。所有受试者均在家中使用标准化采集方法在基线和 24 周访视时采集粪便样本。样本已运往并储存在集中实验室。
标本采集于 2014 年 12 月开始,并于 2016 年 5 月完成。已提取粪便水和 DNA,并正在通过靶向代谢物分析对粪便代谢物和 16S rRNA 基因测序对粪便微生物群进行分析。
本文描述了一项研究的原理和设计,该研究可能为女性 FI 的治疗带来范式转变。