Curcumin in Pediatric Inflammatory Bowel Disease

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

Sponsors

Lead Sponsor: Seattle Children's Hospital

Source Seattle Children's Hospital
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.

Overall Status Completed
Start Date 2009-05-01
Completion Date 2010-06-01
Primary Completion Date 2010-06-01
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
To determine the tolerability of curcumin in pediatric patients with inflammatory bowel disease. 9 Weeks
Enrollment 11
Condition
Intervention

Intervention Type: Drug

Intervention Name: Curcumin

Description: 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.

Eligibility

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 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

Gender:

All

Minimum Age:

8 Years

Maximum Age:

18 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
David Suskind, MD Principal Investigator Seattle Children's Hospital
Overall Contact Contact information is only displayed when the study is recruiting subjects.
Location
Facility: Seattle Children's Hosptial
Location Countries

United States

Verification Date

2010-06-01

Responsible Party

Name Title: David Suskind, MD

Organization: Seattle Children's Hospital

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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