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 @ 2:36 AM
Ignite Modification Date:
2025-12-25 @ 2:36 AM
NCT ID:
NCT03336034
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 75 years;
* A diagnosis of IBS-C according to Rome IV criteria:
Recurrent abdominal pain, on average, at least 1 day per week in the last 3 months, associated with 2 or more of the following criteria: 1) Relation to defecation; 2) Association with a change in stool frequency; 3) Association with a change in stool form (appearance). Criteria fulfilled for the last 3 months with symptom onset at least 6 months ago. Reported stool consistency over the last 3 months: At least 25% of bowel movements are hard and lumpy stools (BSFS 1 or 2) and less than 25% of bowel movements are watery stools (BSFS 6 or 7).
* Negative colonoscopy in the past 5 years prior to inclusion;
* Treatment in primary care unsuccessful for 12 months;
* Ability to understand, read and speak the Dutch language;
* Ability to understand how to utilize the MEASuRE app on a smartphone.
Exclusion Criteria:
* Appendectomy or cholecystectomy within 2 months or other abdominal surgeries within 6 months before entry into the study;
* A history of laxative abuse;
* Current use of drugs that could initiate constipation (e.g. narcotics);
* Use of any IBS-related drugs possibly causing constipation (e.g. tricyclic antidepressants) are a reason for exclusion, unless usage is on a stable dose for at least 30 days before inclusion and there is no plan to change the dose during the study period.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03336034
Study Brief:
Protocol Section:
NCT03336034