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 @ 1:09 PM
Ignite Modification Date:
2025-12-24 @ 1:09 PM
NCT ID:
NCT00889161
Eligibility Criteria:
Inclusion Criteria:
* Children and adolescents eight to eighteen years old
* Diagnosis of inflammatory bowel disease (IBD) made by a pediatric gastroenterologist based upon history, physical examination, laboratory/radiological studies and gastrointestinal histology
* Mild disease or in clinical remission based upon PUCAI or PCDAI score (score \<34 on the PUCAI or score \<30 on the PCDAI)
* Parent/guardian and participant must be able to attend study visits at screening, baseline, and weeks three, six, and nine
* Patient must be on a stable dose of IBD medications for at least 3 months
* Patient must be able to swallow study medication
Exclusion Criteria:
* Abnormal laboratory values as defined in the protocol
* History of increased gastrointestinal symptoms ("flare") in the last 3 months
* Current use (past use of these medications is not an exclusion) of medications such as azathioprine, methotrexate or 6-mercaptopurine used to treat IBD
* Current use (past use of these medications is not an exclusion) of medications or over-the-counter treatments including but not limited to aspirin, NSAID, botanical treatments (ginger, feverfew, yellow clover, Salix species, Populus species, Betula species, and Gaultheria species), essential fatty acids (flax oil and fish oil). Allowed supplementation includes multivitamin, vitamin D \& calcium, folate and vitamin B12, and Iron.
* Other serious medical conditions such as neurological, liver, kidney, auto- immune or systemic disease.
* History of gastrointestinal surgery or planned gastrointestinal surgery in the future.
* Tobacco, alcohol, or illicit drug abuse
* Planned surgery during the potential study participation time
* Inability to swallow study medication
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
18 Years
Study:
NCT00889161
Study Brief:
Protocol Section:
NCT00889161