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
Minimum age: 8 Years.
Maximum age: 18 Years.
- 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
- 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
- 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
- History of gastrointestinal surgery or planned gastrointestinal surgery in the
- Tobacco, alcohol, or illicit drug abuse
- Planned surgery during the potential study participation time
- Inability to swallow study medication