Multidimensional Risk Factor Assessment in Constipation

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.

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Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Risk Factors Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Queen Mary University of London

London, E1 2AJ, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for cases:

Adult men or women (18-65 years)
Symptoms of constipation for a minimum of 3 months
Recruitment based on simplified core ROME III diagnostic criteria for functional constipation
Average Bristol stool type of 1-4 AND frequency of 1-3 spontaneous bowel movements per week
Cleveland Clinic constipation score (CCCS) of 8-15

Inclusion criteria

for controls:

Adult men or women (18-65 years)
Healthy individuals without any coexisting acute or chronic disease
Not meeting simplified core ROME III diagnostic criteria for functional constipation
Average Bristol stool type of 2-5 AND frequency of 3-21 spontaneous bowel movements per week
Cleveland Clinic constipation score (CCCS) of < 8

Exclusion criteria

for both cases and controls:

Pregnant or breastfeeding women
Ongoing other diagnosed gastrointestinal disease or complication
Alarm features such as sudden weight loss, rectal bleeding, recent change in bowel habit (<3 months), abdominal pain and stool positive for occult blood
Prior GI surgery except cholecystectomy, appendicectomy and simple vaginal hysterectomy
Neurologic diseases
Ongoing therapy with drugs known to affect gut motility
Subjects with comorbid illnesses such as cardiovascular, endocrine, renal or other chronic disease likely to affect gut motility or limit normal functions
Self-reported symptoms of pelvic organ prolapse
Moderate or severe active local anorectal problems
Incapacity to consent
Aged under 18 or over 65 years
Any inclusion criteria listed above not met

Treatment and study plan

Primary outcomes

Whole gut transit time

Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Aug 30, 2016
Registry last updated: Dec 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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