Curcumin in Pediatric Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 4 October 2021
• Main ID: NCT02277223
• Date of registration: 25/10/2014
• Prospective Registration: Yes
• Primary sponsor: Schneider Children's Medical Center, Israel
• Public title: Curcumin in Pediatric Ulcerative Colitis
• Scientific title: Curcumin for Induction and Maintenance Therapy in Pediatric Ulcerative Colitis
• Date of first enrolment: March 1, 2020
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02277223
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider).
• Phase: Phase 3

Countries of recruitment

Israel

Contacts

• Name: Amit Assa, MD
• Affiliation: Schneider Children's Medical Center

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Diagnosis of UC, established by the presence of accepted clinical, radiologic,
endoscopic and histologic criteria.

2. Age: 6 - 18 years (inclusive).

3. PUCAI 10-65 at enrollment

4. Negative stool culture, parasites and clostridium toxin

5. Ability and acceptance to participate in the study and follow study procedures, as
evidenced by a parent/legal guardian signing a written informed consent and the child
providing assent.

Exclusion Criteria:

1. Acute severe UC (PUCAI>65 points) requiring IV corticosteroids.

2. History of two relapses or more on 5-ASA treatment.

3. Pregnancy

4. Sepsis or active bacterial infection

5. Fever >38.5 degrees.

6. Patients whose disease is confined to the rectum (i.e. proctitis).

7. Patients with crohn's colitis or with IBD type unclassified (IBD-U) according to
Montreal classification.

8. Rectal therapies (suppositories, foams, enemas etc) of all kind are allowed if the
dose and frequency has remained stable during the previous 14 days prior to the
screening visit.

9. Known allergy to 5ASA, salicylates, or aminosalicylates.

10. History of recurrent pancreatitis.

11. Existence of current renal disease, or a screening blood urea nitrogen (BUN) or
creatinine value that is > 1.5 times the upper limit of the age appropriate normal.

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Age minimum: 6 Years
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Dietary Supplement: Curcumin

Drug: Placebo

Primary Outcome(s)

A change in disease activity, defined by PUCAI at 2 weeks and 6 months [Time Frame: 6 months]

Secondary Outcome(s)

The need for further medical interventions (e.g topical 5-ASA) during the maintenance phase [Time Frame: 6 months]

Sustained clinical remission, 2 weeks and 6 months [Time Frame: 6 months]

Medication associated adverse events [Time Frame: 6 months]

Time to relapse [Time Frame: 6 months]

Secondary ID(s)

PUCC 1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors