Multidimensional Risk Factor Assessment in Constipation (version 1.0)
Research type
Research Study
Full title
Physiological, Environmental and Demographic Alterations in Constipation: A Case Control Study
IRAS ID
179787
Contact name
Mark Scott
Contact email
Sponsor organisation
Joint Research Management Office (JRMO) Queen Mary Innovation Centre
Duration of Study in the UK
1 years, 7 months, 31 days
Research summary
Background: Constipation has a prevalence of approximately 15% and its management remains challenging. Although not life-threatening, it is associated with impaired quality of life, increased health-care costs and more days away from work. Constipation is a disorder with many different causes. 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. However, there is lack of large epidemiological studies assessing all proposed risk factors of constipation together.
Aim: The overall aim of this study is to compare physiological measures of gut health (transit time, female sex hormone levels, stool markers, markers of fermentation) as well as environmental measures (diet, physical activity, anxiety, smoking) and demographic measures (age, gender, body mass index) between patients suffering from constipation and healthy individuals.
Study Design: This is a large single centre case control study comparing constipated adults with healthy individuals matched for age, gender and ethnicity.
Methods: The duration of the study will be 2 weeks in total and will include a screening visit, a 2 week run-in period and a baseline visit at the end of the run-in period. The time it takes for food to travel through the gut (transit time) will be assessed at baseline visit. Differences in gastrointestinal symptoms, dietary intake as well as differences in stool output (stool frequency and consistency) between constipated and healthy individuals will be assessed over the baseline period (the week before baseline visit). Differences in stool markers and markers of fermentation (gut bacteria, stool pH, short chain fatty acids) between constipated and healthy individuals will be 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 will be also assessed at baseline.
REC name
London - Dulwich Research Ethics Committee
REC reference
15/LO/1470
Date of REC Opinion
19 Oct 2015
REC opinion
Further Information Favourable Opinion