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 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT05461833
Eligibility Criteria:
Inclusion Criteria
* age 18-65 years
* PI-IBS diagnosis in accordance with the Rome IV criteria
* moderate-severe disease activity (as determined by an IBS-Symptom Severity Score ≥175)
* normal appearing colon on colonoscopy with biopsy that did not reveal pathology
* signed inform consent.
Exclusion Criteria:
* systemic disease, immunodeficiency, or previous treatment with immunomodulators;
* pregnant or breastfeeding;
* previous surgery on the abdominal cavity, with the exception of appendectomy, cholecystectomy, caesarean section and hysterectomy;
* severe current disease (hepatic, renal, respiratory, or cardiovascular);
* probiotic or antibiotic use within 8 weeks prior to study initiation;
* any condition or circumstance that would, in the opinion of the investigator, prevent completion of the study or interfere with analysis of study results.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05461833
Study Brief:
Protocol Section:
NCT05461833