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临床试验/NCT02884167
NCT02884167已完成不适用

Multidimensional Risk Factor Assessment in Constipation

Queen Mary University of London1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2016年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
170
试验地点
1
主要终点
Whole gut transit time

研究概览

简要总结

Constipation is a symptom based disorder with a prevalence of 15% in the adult population and its management remains challenging. Although not life threatening, constipation is associated with impaired quality of life, increased healthcare costs and excess work absenteeism. Constipation represents a heterogeneous disorder with a multifactorial pathogenesis. Several risk factors have been suggested to lead to the condition and are divided in 3 main categories: a) physiological, b) environmental and c) demographic. To date, there is lack of large epidemiological studies on proposed aetiological factors of constipation, especially studies assessing all proposed risk factors of constipation together.

The overall aim of this study is to investigate the multidimensional (physiological, environmental and demographic) predictors of constipation with the use of a multivariate analysis statistical model.

This is a large single centre case control study comparing constipated adults with healthy individuals matched for age, gender and ethnicity.

The duration of the study is 2 weeks in total and includes a screening visit, a 2 week run-in period and a baseline visit at the end of the run-in period. Transit time between constipated and healthy individuals is assessed at baseline visit. Differences in gastrointestinal symptoms, dietary intake as well as differences in stool output (e.g. stool frequency and consistency) between constipated and healthy individuals are assessed over the baseline period (the week before the baseline visit). Differences in female sex hormone levels as well as stool markers and markers of fermentation (e.g. fecal water, stool pH, short chain fatty acids) between constipated and healthy individuals are assessed at baseline visit. Furthermore, differences in environmental measures (physical activity, anxiety, smoking) and differences in demographic measures (age, gender, body mass index) between patients suffering from constipation and healthy individuals are also assessed at baseline visit.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Whole gut transit time

时间窗: Baseline

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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