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Curcumin in Pediatric Inflammatory Bowel Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Curcumin in Pediatric Inflammatory Bowel Disease

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

NCT00889161•Seattle Children's Hospital

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

Age

8 - 18 years

Sex

ALL

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

Locations (1)

Seattle Children's Hosptial

Seattle, Washington, United States

Key Dates

Start Date

May 1, 2009

Primary Completion Date

June 1, 2010

Completion Date

June 1, 2010

Last Updated

June 22, 2010

Enrollment

ACTUAL participants

Conditions

Inflammatory Bowel DiseaseUlcerative ColitisCrohn's Disease

Interventions

Curcumin

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 22, 2010Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Curcumin in Pediatric Inflammatory Bowel Disease

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

Impact of Morning Light Therapy in IBD

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An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease