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Trial record 56 of 167 for:    Curcumin | curcumin

Curcumin in Pediatric Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT02277223
Recruitment Status : Not yet recruiting
First Posted : October 28, 2014
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Amit Assa, Schneider Children's Medical Center, Israel

Tracking Information
First Submitted Date  ICMJE October 25, 2014
First Posted Date  ICMJE October 28, 2014
Last Update Posted Date September 18, 2019
Estimated Study Start Date  ICMJE December 1, 2019
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2014)
A change in disease activity, defined by PUCAI at 2 weeks and 6 months [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02277223 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2014)
  • 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 ]
  • The need for further medical interventions (e.g topical 5-ASA) during the maintenance phase [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Curcumin in Pediatric Ulcerative Colitis
Official Title  ICMJE Curcumin for Induction and Maintenance Therapy in Pediatric Ulcerative Colitis
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.
Detailed Description Clinical efficacy of induction and maintenance medications in pediatric UC is limited with a cumulative long-term risk of 20%-30% for colectomy. Remission rates following induction with corticosteroids and 5-amino-salicylic acid (5-ASA) range from 20% to 50%. 5-ASA is still regarded as first line induction and maintenance therapy for mild to moderate UC in both children and adults. 5-ASA is also indicated for maintenance therapy following successful induction with corticosteroids for moderate to severe disease. Still, steroid free clinical remission at 1 year under 5-ASA maintenance therapy is reported to range from 40% to 50%. Management of recurrent flares while taking 5-ASA medications involves repeated courses of corticosteroids and changing therapeutic regimes to include more potent medications such as thiopurines which carry an increased risk for significant adverse effects. Hence, improving efficacy of induction and maintenance treatment is of critical importance. Curcumin, an active phytochemical substance with anti-inflammatory properties was studied extensively in-vitro and in experimental models of colitis. In the only randomized controlled trial, performed in adults with quiescent disease, curcumin was shown to be an effective concomitant treatment (along with 5-ASA) for maintenance of remission. Therefore, our aim is to assess the efficacy of concomitant curcumin maintenance therapy for induction and maintenance therapy in pediatric UC patients with mild to moderate in a prospective randomized, placebo controlled trial. We hope that this study will further contribute to the understanding of the potential benefits of curcumin in pediatric UC patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE
  • Dietary Supplement: Curcumin

    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.

    Other Name: Tumeric
  • Drug: Placebo

    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.

    Other Name: Matched placebo
Study Arms  ICMJE
  • Experimental: Interventional
    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
    Intervention: Dietary Supplement: Curcumin
  • Placebo Comparator: Control
    In addition to induction and maintenance therapy, patients will receive matched oral placebo capsules for induction and maintenance (Bara Herbs Inc), twice daily.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 27, 2014)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2022
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

    -

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Amit Assa, MD 9723543522211 dr.amit.assa@gmail.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02277223
Other Study ID Numbers  ICMJE PUCC 1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amit Assa, Schneider Children's Medical Center, Israel
Study Sponsor  ICMJE Schneider Children's Medical Center, Israel
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Amit Assa, MD Schneider Children's Medical Center
PRS Account Schneider Children's Medical Center, Israel
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP