Curcumin in Pediatric Inflammatory Bowel Disease

NCT00889161 | Completed Phase 1

• 2 other identifiers: Curcumin-11UL1RR025014-01
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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

Keywords

Crohn's disease; ulcerative colitis; curcumin; pediatric; inflammatory bowel disease

Outcome Measures

Primary Outcomes (1)

• To determine the tolerability of curcumin in pediatric patients with inflammatory bowel disease.

  9 Weeks

Interventions

Curcumin DRUG

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

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Abnormal laboratory values as defined in the protocol
• History of increased gastrointestinal symptoms ("flare") in the last 3 months
• 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

Sponsors & Collaborators

• Seattle Children's Hospital: lead

Study Sites (1)

Seattle Children's Hosptial

Seattle, Washington, 98105, United States

Location

Related Publications (1)

• 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.

  PMID: 23059643 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• David Suskind, MD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 24, 2009
• First Posted: April 28, 2009
• Study Start: May 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: June 22, 2010

Record last verified: 2010-06

Locations

US (1)