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临床试验/NCT07283341
NCT07283341招募中不适用

The Role of Diet and Gastrointestinal Motility in Irritable Bowel Syndrome (IBS)

Children's Hospital of Philadelphia1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年7月31日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
90
试验地点
1
主要终点
Gut myoelectric activity in children with IBS and controls using the non-invasive wireless patch system (WPS)

研究概览

简要总结

The goal of this observational study is to identify factors that influence symptoms in children with irritable bowel syndrome (IBS), to find ways to make diet treatments work better and possibly create personalized plans to help each child with IBS feel better. The main question it aims to answer is:

  1. What types of food do the kids eat and how do these diets relate to their symptoms?
  2. Is there any motility pattern that we can identify from the kids with or without IBS using a wearable patch?
  3. What kinds of bacteria and chemicals are found in the gut and urine of children with IBS, and how are these linked to their IBS symptoms?

Participants will use the wearable patch, answer questionnaires, collect stool and urine samples, and recall their 24 hours dietary.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
8 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Males and females age 8 - 18 years
  • Diagnosis of irritable bowel syndrome (IBS).
  • Parental/guardian permission (informed consent) and child assent
  • Males and Females age 8-18 years
  • No diagnosis of abdominal pain disorder
  • Parental/guardian permission (informed consent) and child assent

排除标准

  • Allergy to adhesives
  • Inability to cooperate with study design
  • Antibiotic intake in the past 4 weeks
  • Inflammatory gastrointestinal disorder diagnosis
  • Allergy to adhesives
  • Inability to cooperate with study design
  • Antibiotic intake in the past 4 weeks
  • Inflammatory gastrointestinal disorder diagnosis

结局指标

主要结局

Gut myoelectric activity in children with IBS and controls using the non-invasive wireless patch system (WPS)

时间窗: Approximately one year.

Differences in total activity, pre- and post-prandial activity ratios, nighttime colonic activity, and night-to-day colonic activity ratios between IBS patients and controls. WPS reading will be completed after each study visit. Differences will be compared at the 3rd and 4th quarters of each year.

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 (1)

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