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Curcumin in Pediatric Inflammatory Bowel Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00889161
Recruitment Status : Completed
First Posted : April 28, 2009
Last Update Posted : June 22, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Disease Ulcerative Colitis Crohn's Disease Drug: Curcumin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Curcumin in Pediatric Inflammatory Bowel Disease: A Forced Dose Titration Study
Study Start Date : May 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Intervention Details:
  • Drug: 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.

Primary Outcome Measures :
  1. To determine the tolerability of curcumin in pediatric patients with inflammatory bowel disease. [ Time Frame: 9 Weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00889161

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United States, Washington
Seattle Children's Hosptial
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Seattle Children's Hospital
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Principal Investigator: David Suskind, MD Seattle Children's Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: David Suskind, MD, Seattle Children's Hospital Identifier: NCT00889161    
Other Study ID Numbers: Curcumin-1
1UL1RR025014-01 ( U.S. NIH Grant/Contract )
First Posted: April 28, 2009    Key Record Dates
Last Update Posted: June 22, 2010
Last Verified: June 2010
Keywords provided by Seattle Children's Hospital:
Crohn's disease
ulcerative colitis
inflammatory bowel disease
Additional relevant MeSH terms:
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Crohn Disease
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action