Crohn's Disease, Inflammatory Bowel Disease, Ulcerative Colitis
Conditions
Keywords
Crohn's disease, ulcerative colitis, curcumin, pediatric, inflammatory bowel disease
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 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.
Interventions
DRUGCurcumin
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.
Sponsors
Seattle Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the tolerability of curcumin in pediatric patients with inflammatory bowel disease. | 9 Weeks |
Countries
United States
Outcome results
None listed