Curcumin in Pediatric Ulcerative Colitis

NCT02277223 | Withdrawn Phase 3 DMC

• 1 other identifier: PUCC 1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• A change in disease activity, defined by PUCAI at 2 weeks and 6 months

  6 months

Secondary Outcomes (4)

• Sustained clinical remission, 2 weeks and 6 months

  6 months

• Medication associated adverse events

  6 months

• Time to relapse

  6 months

• The need for further medical interventions (e.g topical 5-ASA) during the maintenance phase

  6 months

Study Arms (2)

Interventional

EXPERIMENTAL

In addition to induction therapy, patients will receive oral capsules of curcumin (Bara Herbs Inc): Weight\<20kg: 1 gram, twice daily, 20-30 kg: 1.5 grams twice daily, weight\>30kg: 2 grams twice daily. For Maintenance, in addition to oral 5-ASA maintenance treatment, responding patients will receive oral capsules of curcumin (Bara Herbs Inc): Weight\<30kg: 500 milligram, twice daily, weight\>30kg: 1 gram twice daily

Dietary Supplement: Curcumin

Control

PLACEBO COMPARATOR

In addition to induction and maintenance therapy, patients will receive matched oral placebo capsules for induction and maintenance (Bara Herbs Inc), twice daily.

Drug: Placebo

Interventions

Curcumin DIETARY_SUPPLEMENT

Eligible patients will be randomized to either intervention of placebo groups. Randomization will be performed separately for patients receiving corticosteroids for induction in-order to ensure similar heterogeneity within groups. Induction: oral prednisone 1mg/kg up to 40 mg once daily for 2 weeks and then tapered down by 5 mg per week or 5-ASA 75 mg/kg/day divided to two doses. Maintenance: 5-ASA 75 mg/kg/day divided to two doses. Patients receiving corticosteroids for induction, whose PUCAI is \>35 points at 2 weeks will be regarded as treatment failure. Patients receiving 5-ASA for induction with "induction treatment failure" will be re-randomized to receive oral corticosteroids induction with or without curcumin.

Also known as: Tumeric

Interventional

Placebo DRUG

Eligible patients will be randomized to either intervention of placebo groups. Randomization will be performed separately for patients receiving corticosteroids for induction in-order to ensure similar heterogeneity within groups. Induction: oral prednisone 1mg/kg up to 40 mg once daily for 2 weeks and then tapered down by 5 mg per week or 5-ASA 75 mg/kg/day divided to two doses. Maintenance: 5-ASA 75 mg/kg/day divided to two doses. Patients receiving corticosteroids for induction, whose PUCAI is \>35 points at 2 weeks will be regarded as treatment failure. Patients receiving 5-ASA for induction with "induction treatment failure" will be re-randomized to receive oral corticosteroids induction with or without curcumin.

Also known as: Matched placebo

Control

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of UC, established by the presence of accepted clinical, radiologic, endoscopic and histologic criteria.
• Age: 6 - 18 years (inclusive).
• PUCAI 10-65 at enrollment
• Negative stool culture, parasites and clostridium toxin
• 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.

You may not qualify if:

• Acute severe UC (PUCAI\>65 points) requiring IV corticosteroids.
• History of two relapses or more on 5-ASA treatment.
• Pregnancy
• Sepsis or active bacterial infection
• Fever \>38.5 degrees.
• Patients whose disease is confined to the rectum (i.e. proctitis).
• Patients with crohn's colitis or with IBD type unclassified (IBD-U) according to Montreal classification.
• 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.
• Known allergy to 5ASA, salicylates, or aminosalicylates.
• History of recurrent pancreatitis.
• 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.

Sponsors & Collaborators

• Schneider Children's Medical Center, Israel: lead

Study Sites (1)

Schneider Medical Center

Petah Tikva, 4259000, Israel

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Amit Assa, MD

  Schneider Children's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Gastroenterologist

Study Record Dates

• First Submitted: October 25, 2014
• First Posted: October 28, 2014
• Study Start: March 1, 2020
• Primary Completion: July 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 1, 2021

Record last verified: 2021-09

Locations

IL (1)