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 @ 4:46 PM
Ignite Modification Date:
2025-12-24 @ 4:46 PM
NCT ID:
NCT03831750
Eligibility Criteria:
Inclusion Criteria (RCT):
* Adults (≥18 years)
* with IBD in remission (UC - partial Mayo \<2 and fecal calprotectin \<250 μg/g; CD regular HBI \<5 or CRP \<8)
* on stable therapy for the past 3 months
* the last flare \<24 months prior to enrollment
* PSS-10 score ≥ 7 at time of screening
Inclusion Criteria (Substudy):
* Adults (≥18 years)
* IBD
* on stable therapy for the past 3 months.
Exclusion Criteria (RCT or Substudy):
* Major medical co-morbidity
* Steroid use in past 3 months
* Clostridium difficile infection in the last 3 months
* Unstable dose of psychiatric medications for the last 3 months
* Inability to provide informed written consent
* Severe psychiatric disorders (HADS scores \>10 or suicidal ideation)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT03831750
Study Brief:
Protocol Section:
NCT03831750