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Curcumin in Pediatric Inflammatory Bowel Disease

Information source: Seattle Children's Hospital
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Inflammatory Bowel Disease; Ulcerative Colitis; Crohn's Disease

Intervention: Curcumin (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Seattle Children's Hospital

Official(s) and/or principal investigator(s):
David Suskind, MD, Principal Investigator, Affiliation: Seattle Children's Hospital

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.

Clinical Details

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

Study design: Treatment, Open Label, Single Group Assignment

Primary outcome: To determine the tolerability of curcumin in pediatric patients with inflammatory bowel disease.

Eligibility

Minimum age: 8 Years. Maximum age: 18 Years. Gender(s): Both.

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

Locations and Contacts

Seattle Children's Hosptial, Seattle, Washington 98105, United States; Recruiting
Melissa J Coffey, BA, Phone: 206-987-1062, Email: melissa.coffey@seattlechidlrens.org
David Suskind, MD, Principal Investigator
Additional Information

Starting date: May 2009
Ending date: May 2010
Last updated: September 18, 2009

Page last updated: October 19, 2009

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