Status:
COMPLETED
Curcumin in Pediatric Inflammatory Bowel Disease
Lead Sponsor:
Seattle Children's Hospital
Conditions:
Inflammatory Bowel Disease
Ulcerative Colitis
Eligibility:
All Genders
8-18 years
Phase:
PHASE1
Brief Summary
This is a single center, open label forced dose titration study designed to determine the tolerability of curcumin in pediatric patients with inflammatory bowel disease (IBD). This study will provide ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00889161
Start Date
May 1 2009
End Date
June 1 2010
Last Update
June 22 2010
Active Locations (1)
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1
Seattle Children's Hosptial
Seattle, Washington, United States, 98105