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Curcumin in Pediatric Inflammatory Bowel Disease

Primary Purpose

Inflammatory Bowel Disease, Ulcerative Colitis, Crohn's Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Curcumin
Sponsored by
Seattle Children's Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Disease focused on measuring Crohn's disease, ulcerative colitis, curcumin, pediatric, inflammatory bowel disease

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seattle Children's Hosptial

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 24, 2009
Last Updated
June 16, 2010
Sponsor
Seattle Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00889161
Brief Title
Curcumin in Pediatric Inflammatory Bowel Disease
Official Title
Curcumin in Pediatric Inflammatory Bowel Disease: A Forced Dose Titration Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Seattle Children's Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease, Ulcerative Colitis, Crohn's Disease
Keywords
Crohn's disease, ulcerative colitis, curcumin, pediatric, inflammatory bowel disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Curcumin
Intervention Description
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 Measure Information:
Title
To determine the tolerability of curcumin in pediatric patients with inflammatory bowel disease.
Time Frame
9 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Suskind, MD
Organizational Affiliation
Seattle Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seattle Children's Hosptial
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23059643
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.
Results Reference
derived

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Curcumin in Pediatric Inflammatory Bowel Disease

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