Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT02884167
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02884167
Study Brief:
Protocol Section:
NCT02884167