| Trial name or title |
Curcumin in Pediatric Inflammatory Bowel Disease |
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| Methods |
Double blinded placebo controlled study |
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| Participants |
Age: 8 to 18 years |
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Gender: Both |
| 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
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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
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| Interventions |
Curcumin at an initial dosage of 500 mg twice a day for 3 weeks. Using the forced dose titration design, dose will be titrated up to 1g twice a day at Week 3 for a total of three weeks and then titrated again to 2 g twice a day at Week 6 for three weeks |
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| Outcomes |
Tolerability and safety data in pediatric patients with IBD |
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| Starting date |
May 2009 |
|
| Contact information |
David Suskind MD, Seattle Children’s Hosptial, Seattle, Washington, United States, 98105 |
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| Notes |
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