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 @ 7:59 PM
Ignite Modification Date:
2025-12-24 @ 7:59 PM
NCT ID:
NCT03863704
Eligibility Criteria:
Inclusion Criteria:
1. Age 10-21 years
2. IBD diagnosis for at least 3 months, confirmed by clinical, biochemical, and endoscopic evaluations
3. Elevated Fecal calprotectin ≥ 200 ug/g within the past 4 weeks prior to enrollment
4. Evidence of active inflammatory disease despite treatment with at least one conventional therapy
5. If on corticosteroids, the dose must be stable and ≤ 10mg/day (prednisone or equivalent) for at least 14 days before entry into study
6. If on 5-Aminosalicylate, dose must be stable with following parameters:
* 28 days on oral medication
* Prior to baseline calprotectin, 28 days on rectal medication or 2 weeks off rectal medication
7. If on background immunosuppressive treatment the dose must be stable with the following parameters:
* 56 days (8 weeks) for Immunomodulators (methotrexate, 6-MP, Azathioprine)
* 112 days (16 weeks) for Infliximab, Adalimumab, Vedolizumab, Ustekinumab, other biologic
8. Able and willing to give written informed consent and comply with the requirements of the study protocol.
Exclusion Criteria:
1. Expectation to increase corticosteroids and/or immunosuppressive treatment
2. Presence of bowel stricture with prestenotic dilatation
3. Presence of intra-abdominal or perirectal abscess
4. Pediatric UC activity Index (PUCAI) score ≥ 65 (severe)
5. weighted Pediatric Crohn Disease Activity Index (wPCDAI) score \> 57.5 (severe)
6. Active treatment with antibiotics
7. Presence of active intestinal infection or documented infection by stool PCR or culture analysis in the previous 6 weeks
8. Continuous treatment with an anti-cholinergic medication, including over the counter medications
9. Implantable electronic devices such as pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators.
10. Current tobacco or nicotine user (to limit potential confounding effects of exposure to nicotine)
11. Bowel resection surgery within past 90 days prior to study enrollment and on no conventional IBD therapy, or planned surgery within the course of the study
12. Any planned surgical procedure requiring general anesthesia within the course of the study
13. Participation in any other Investigational drug and/or treatment currently or planned during the length of the study
14. Any condition which, in the opinion of the investigator, would jeopardize the subject's safety following exposure to a study intervention
15. Pregnancy or Lactation
16. Comorbid disease with high likelihood of requiring corticosteroid use
17. Inability to comply with study and follow-up procedures
18. Non-English speaking
19. Known cardiac condition causing or with potential to cause arrhythmia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
21 Years
Study:
NCT03863704
Study Brief:
Protocol Section:
NCT03863704