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Curcumin in Pediatric Inflammatory Bowel Disease

This study has been completed.
Information provided by:
Seattle Children's Hospital Identifier:
First received: April 24, 2009
Last updated: June 16, 2010
Last verified: June 2010
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 Intervention Phase
Inflammatory Bowel Disease
Ulcerative Colitis
Crohn's Disease
Drug: Curcumin
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Curcumin in Pediatric Inflammatory Bowel Disease: A Forced Dose Titration Study

Resource links provided by NLM:

Further study details as provided by Seattle Children's Hospital:

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

Enrollment: 11
Study Start Date: May 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
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.

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
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Please refer to this study by its identifier: NCT00889161

United States, Washington
Seattle Children's Hosptial
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Seattle Children's Hospital
Principal Investigator: David Suskind, MD Seattle Children's Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: David Suskind, MD, Seattle Children's Hospital Identifier: NCT00889161     History of Changes
Other Study ID Numbers: Curcumin-1
1UL1RR025014-01 ( US NIH Grant/Contract Award Number )
Study First Received: April 24, 2009
Last Updated: June 16, 2010

Keywords provided by Seattle Children's Hospital:
Crohn's disease
ulcerative colitis
inflammatory bowel disease

Additional relevant MeSH terms:
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 processed this record on May 25, 2017