跳至主要内容
临床试验/NCT03510052
NCT03510052已完成不适用

Diet Modification Program for Senior Women With Fecal Incontinence

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2018年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
55
试验地点
2
主要终点
Change in FI Symptoms (Vaizey)

研究概览

简要总结

Investigators will conduct a single-arm pre-post intervention pilot study in 46 older women with Fecal Incontinence (FI), also known as Accidental Bowel Leakage (ABL). FI symptoms and stool metabolites will be measured at baseline. Intervention with the Diet Modification Program (DMP) will be administered. FI symptoms and stool metabolites will be measured after 6weeks of the intervention.

详细描述

Study Procedure: Visit Schedule

Visit 1(Baseline visit): Following consent, the study coordinator will obtain participant's demographic data including age, race/ethnicity, body mass index. Data on medical comorbidities, surgical history and medications known to be associated with FI will be collected. The participant's severity of FI will be measured using the St. Mark's Vaizey scale (Vaizey). The impact of FI on quality of life will be measured using the Fecal Incontinence Quality of Life scale (FIQL). The presence, type, and severity of other pelvic floor symptoms known to be associated with FI will be assessed using the Pelvic floor Distress Inventory- Short Form. Participants will be given a Food and Bowel Symptom diary and a stool collection kit at the conclusion of the visit.

Visit 2(Intervention visit): Stool sample will be collected by the study coordinator. Investigators will administer the DMP. Participants will be given the booklet outlining the DMP and investigators will review the participant's Food and Symptom diary and provide targeted recommendations. The participant will be given a second Food and Symptom diary and stool collection kit to return 6 weeks after the intervention start date.

Calls: Trained Nutritionists will call the participant between weeks 2 and 4 for three unannounced 24h diet recall. The 24-hour dietary recalls will be collected using Nutrition Data System for Research, a computer-based software application that facilitates the collection of recalls in a standardized fashion.

Visit 3 (Follow up visit): Post intervention stool samples and Food and Symptom diary will be collected. Questionnaires including the Vaizey, FIQL, Pelvic Floow Disability Index (PFDI), and Patient Global Index of Improvement (PGI-I) will be administered by the study coordinator. Participants will receive compensation for participating in the study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age ≥ 65 years,
  • FI 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,
  • adequate mobility for independent toileting,
  • ability for independent completion of food symptom diary,
  • has some control of her diet and is able to make adjustments
  • able to read and communicate in English,
  • willing to give informed consent

排除标准

  • Currently receiving another treatment for FI
  • significant cognitive impairment at baseline
  • residence in a care facility that provides meals (participants who are not able to adjust their diet will be excluded because the intervention focuses on the participant, not their care facility)
  • current bloody diarrhea,
  • current or past diagnosis of colorectal

结局指标

主要结局

Change in FI Symptoms (Vaizey)

时间窗: 6 weeks

Changes in the participant's symptom severity will be assessed from baseline to study conclusion.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Diet and Fecal Incontinence in Senior Women | 临床试验