Curcumin in Pediatric Inflammatory Bowel Disease

NCT ID: NCT00889161

Last Updated: 2010-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2010-06-30

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.

Conditions

Inflammatory Bowel Disease; Ulcerative Colitis; Crohn's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seattle Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Seattle Children's Hospital

Principal Investigators

David Suskind, MD

Role: PRINCIPAL_INVESTIGATOR

Seattle Children's Hospital

Locations

Seattle Children's Hosptial

Seattle, Washington, United States

Countries

United States

References

Suskind DL, Wahbeh G, Burpee T, Cohen M, Christie D, Weber W. Tolerability of curcumin in pediatric inflammatory bowel disease: a forced-dose titration study. J Pediatr Gastroenterol Nutr. 2013 Mar;56(3):277-9. doi: 10.1097/MPG.0b013e318276977d.

Reference Type: DERIVED

PMID: 23059643 (View on PubMed)

Other Identifiers

1UL1RR025014-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Curcumin-1

Identifier Type: -

Identifier Source: org_study_id