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 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT02391220
Eligibility Criteria:
Inclusion Criteria:
* Confirmed constipation-predominant irritable bowel syndrome (on the basis of Rome III criteria) (≥ 25 % lumpy or hard stools and ≤ 25 % mushy or watery stools).
* Meeting Rome III criteria for the determination of irritable bowel syndrome in the last 6 months prior to inclusion and the presence of symptoms such as abdominal pain, bloating and general digestive discomfort at least twice a week in the last 3 months prior to inclusion.
* Colonoscopy in the last 7 years prior to inclusion with normal results.
Exclusion Criteria:
* Diarrhoea-predominant irritable bowel syndrome (≥ 25 % mushy or watery stools and ≤ 25 % lumpy or hard stools).
* Clinical signs of alarm, such as rectorrhagia, fever, recent unexplained weight loss.
* Organic gastrointestinal diseases, including chronic inflammatory bowel disease and systemic diseases with gastrointestinal difficulties.
* Severe abdominal pain and the taking of analgesics or antispasmodics for the previous 5 days or more.
* Having begun treatment with psychotropic medicines or other drugs for the treatment of irritable bowel syndrome within the previous month.
* Dietary habits that could influence the assessment of the investigational product, such as slimming or a vegetarian diet.
* Known allergy to ingredient(s) in the investigational product.
* Known medical or psycho-physical condition that is, in the opinion of the investigator, in conflict with consumption of the investigational product and/or the course of the study.
* Participation in another clinical study less than one month before inclusion or concurrent participation in another clinical study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02391220
Study Brief:
Protocol Section:
NCT02391220