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:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT07094035
Eligibility Criteria:
Inclusion Criteria:
* aged between 18 and 70 years
* able to understand and sign informed consent
* HIV negative test
* negative pregnancy test
* With IBS symptoms for at least 3 months (with onset at least 6 months earlier)
* recurrent abdominal pain at least 1 day a week, associated with two or more of the following criteria: associated with the act of defecation, associated with a change in the frequency of bowel movements, associated with a change in the shape of the stool (Rome IV diagnostic criteria)
* who have less than three BM/wk and at least one of the following conditions:
* in more than 25%\* of defecatory acts
* lumpy or hard stools (BSFS type 1 or 2) in more than 25% of bowel movements
* feeling of incomplete evacuation in more than 25% of defecations
* feeling of anorectal obstruction/blockage in more than 25% of defecations
* carry out manual manoeuvres to facilitate evacuation in more than 25% of defecations
* Able to understand and comply with the requirements of the protocol.
Exclusion Criteria:
* pregnancy
* lactation
* HIV positive
* do not meet inclusion criteria.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07094035
Study Brief:
Protocol Section:
NCT07094035