Clinical trial NCT00889161: Curcumin in Pediatric Inflammatory Bowel Disease
Official title: Curcumin in Pediatric Inflammatory Bowel Disease: A Forced Dose Titration Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Inflammatory Bowel Disease
Ulcerative Colitis
Crohn's Disease
Keywords: Crohn's disease
ulcerative colitis
curcumin
pediatric
inflammatory bowel disease
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
First posted: 2009-04-28
Enrollment: 11
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: To determine the tolerability of curcumin in pediatric patients with inflammatory bowel disease.
timeFrame: 9 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hosptial
state: Washington
Study officials:
affiliation: Seattle Children's Hospital
name: David Suskind, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.