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 @ 3:00 AM
Ignite Modification Date:
2025-12-25 @ 3:00 AM
NCT ID:
NCT06738433
Eligibility Criteria:
Inclusion Criteria:
* Subjects who require hospitalization
* Constipation defined as the Rome IV criteria for constipation
* Patients with the ability to take the study product orally
Exclusion Criteria:
* History of allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active principle or to any of the excipients.
* History or evidence of any medical conditions or medication used that, in the opinion of the principal investigator, could affect the safety of the subjects or interfere with the study evaluations
* Patients last palliative care en stage of "end of life" or "terminal"
* Amytriptilin (anti-depressive) and masalazine (anti-inflammatory) treatment
* Laxatives
* Antibiotic treatment in the previous 2 weeks
* Patients with IBS or any other gastrointestinal conditions that maybe the cause of the constipation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06738433
Study Brief:
Protocol Section:
NCT06738433