Curcumin in Pediatric Inflammatory Bowel Disease

Study Overview
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Brief Summary
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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 initial tolerability and safety data in pediatric patients with IBD. Twenty patients with IBD in remission or with mild disease (score <34 on PUCAI or score <30 on the PCDAI) on sulfasalazine or mesalamine aged 8 to 18 years will be enrolled into this study. Each patient will participate in the study for nine weeks. From this study an appropriate dosage will be determined to proceed with a double blinded placebo controlled study.

Official Title
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Curcumin in Pediatric Inflammatory Bowel Disease: A Forced Dose Titration Study

Conditions
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Inflammatory Bowel Disease, Ulcerative Colitis, Crohn's Disease

Intervention / Treatment
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* Drug: Curcumin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Curcumin|Initial dosage of 500mg 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 2g twice a day at Week 6 for three weeks.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the tolerability of curcumin in pediatric patients with inflammatory bowel disease. |  | 9 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's disease, ulcerative colitis, curcumin, pediatric, inflammatory bowel disease