Curcumin in Pediatric Ulcerative Colitis

• Status: Withdrawn
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Background: Curcumin in an active phytochemical substance, used as part of the human diet, that has anti-inflammatory and anti-oxidative properties which were demonstrated in multiple experimental models of colitis including a positive effect on maintenance of remission in adult ulcerative colitis (UC) patients. Objectives: To examine the effect of curcumin as complementary medication in induction and maintenance therapy in pediatric patients with mild to moderate ulcerative colitis. Design: A prospective, randomized, placebo-controlled study. Setting: Pediatric gastroenterology centers. Participants: Children 6 year to 18 years who are diagnosed with mild to moderate UC and are planned to receive either 5-ASA or corticosteroids induction treatment. Main outcome measures: Disease activity defined by the Pediatric Ulcerative Colitis Activity Index (PUCAI) at 2 weeks and 6 months. Secondary outcome measures: Effect of curcumin treatment on serum inflammatory markers, calprotectin and fecal microbiota. Data analysis: Data will be collected and analyzed using SPSS (version 21.0, SPSS, Inc., Chicago, IL, USA). Fisher's exact test will be used to explore univariate associations between primary outcomes and categorical variables. Associations of continues variables with primary outcome measures will be examined using ANOVA with repeated measures. P-values <0.05 will be considered significant.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Schneider Children's Medical Center, Israel
• Treatments: Curcumin

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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