Curcumin in Pediatric Inflammatory Bowel Disease

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00889161
• Other study ID #: Curcumin-1
• Secondary ID: 1UL1RR025014-01
• Status: Completed
• Phase: Phase 1
• First received: April 24, 2009
• Last updated: June 16, 2010
• Start date: May 2009
• Est. completion date: June 2010

Study information

• Verified date: June 2010
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis

Intervention

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.

Locations

Country	Name	City	State
United States	Seattle Children's Hosptial	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the tolerability of curcumin in pediatric patients with inflammatory bowel disease.		9 Weeks	Yes