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Curcumin for Prevention of Relapse in Patients With Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT03122613
Recruitment Status : Recruiting
First Posted : April 21, 2017
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Siew Chien NG, Chinese University of Hong Kong

Tracking Information
First Submitted Date  ICMJE April 7, 2017
First Posted Date  ICMJE April 21, 2017
Last Update Posted Date June 21, 2019
Actual Study Start Date  ICMJE June 19, 2017
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2017)
The relapse rate at 12 months [ Time Frame: 1 year ]
Defined as clinical symptoms (increased bowel frequency with a bowel frequency Mayo subscore ≥ 1 or rectal bleeding with a Mayo rectal bleeding subscore ≥ 1) together with endoscopic evidence of active disease (Mayo endoscopic subscore ≥ 2).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03122613 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2017)
  • Adverse events [ Time Frame: 1 year ]
    The severity grading of AEs will be assessed as Grade 1, 2, 3, 4 or 5 using the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 Grading Scale, which can be found at: http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_8.5x11.pdf
  • Endoscopic remission [ Time Frame: 1 year ]
    Defined as a mayo endoscopic subscore of 0 or 1
  • Simple Clinical Colitis Activity Index (SCCAI) [ Time Frame: 1 year ]
    compare the scores in two groups
  • Fecal calprotectin levels at 12 months [ Time Frame: 1 year ]
    compare the difference of the levels between groups
  • Fecal immunochemical test (FIT) at 12 months [ Time Frame: 1 year ]
    compare the positivity rate in those with flare
  • Quality of Life assessed by the Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: 1 year ]
    compare the scores in two groups
  • Patient Reported Outcomes (PRO) Questionnaire [ Time Frame: 1 year ]
    The questionnaire will ask during the study follow up about the psychological aspects of UC patients, the baseline and score on final visit will be compared, as well as between the two groups
  • Pharmacokinetics study to measure the drug concentration-time courses [ Time Frame: 1 year ]
    compare the absorption rate in two groups and to establish and evaluate the relationships and subsequently describe the effect-time courses of curcumin absorption in blood and colon.
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 for Prevention of Relapse in Patients With Ulcerative Colitis
Official Title  ICMJE A Double-blind, Randomized, Placebo-Controlled Trial of Curcumin Versus Placebo for Prevention of Relapse in Patients With Ulcerative Colitis
Brief Summary

UC is a chronic inflammatory bowel disorder with relapsing and remitting course. The efficacy of mesalazine in preventing relapse in patients with UC is well-known and supported by randomized studies. However, mesalazine can be associated with side-effects. In addition, drug compliance is suboptimal, especially when disease is not active. Curcumin is a natural phytochemical derived from the Indian spice turmeric. It is widely used, has potent anti-inflammatory, anti-oxidant and anti-tumour properties.

The aims of this double-blind, placebo-controlled randomized trial is to assess the efficacy of curcumin in the prevention of relapse in patients with ulcerative colitis (UC).

Detailed Description

UC is a chronic inflammatory bowel disorder with relapsing and remitting course. The incidence of UC in Hong Kong has increased by 30-fold in the past three decades. The efficacy of mesalazine in preventing relapse in patients with UC is well-known and supported by randomized studies. However, mesalazine can be associated with side-effects. In addition, drug compliance is suboptimal, especially when disease is not active. Without mesalazine, the risk of relapse in UC in one year is approximately 60-70%. Repeated flares are disabling for the patient, and lead to increased hospitalisations, anatomical extension of disease, and increased cancer risk. In Hong Kong, 90 percent of patients with UC have low to medium compliance to mesalazine, and 50 percent would prefer the use of a complementary or alternative therapy to maintain disease remission. Identification of a natural product that is effective, acceptable, inexpensive and non-toxic remains an unmet need in patients with UC.

Curcumin is a natural phytochemical derived from the Indian spice turmeric. It is widely used, has potent anti-inflammatory, anti-oxidant and anti-tumour properties. Preclinical studies in experimental animals showed that curcumin is effective in preventing colitis. We reported in a randomized study that curcumin is effective in the induction of remission in patients with mild to moderately active UC. Although curcumin is popular amongst patients with inflammatory bowel disease, its efficacy in maintaining disease remission in UC is uncertain. We propose a double-blind, placebo-controlled trial to assess the efficacy of curcumin in preventing clinical relapse in patients with UC. Patients will be randomised to 2 gram curcumin once daily or an equivalent placebo for 12 months. The primary outcome is the rate of clinical relapse at 12 months. Secondary outcomes include adverse events, endoscopic remission, fecal calprotectin levels and time to relapse.

Because the use of curcumin is already popular in Asia, this important clinical question will not be a priority of pharmaceutical companies. If proven, this industry-independent trial will be a landmark study that identifies an alternative effective treatment to maintain disease remission in patients with UC. Regardless of the outcome, it will inform clinical practice and provide invaluable data to international guideline committees on the management of this chronic inflammatory disease.

The aims of this double-blind, placebo-controlled randomized trial is to assess the efficacy of curcumin in the prevention of relapse in patients with ulcerative colitis (UC).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Double-blinded using identical looking products in both arms
Primary Purpose: Other
Condition  ICMJE Ulcerative Colitis in Remission
Intervention  ICMJE
  • Dietary Supplement: Curcumin
    3g of Curcumin per day
    Other Name: Turmeric
  • Drug: Placebo
    3g of Curcumin Placebo per day
    Other Name: Curcumin placebo
Study Arms  ICMJE
  • Active Comparator: Curcumin
    Dietary supplements of Curcumin capsules
    Intervention: Dietary Supplement: Curcumin
  • Placebo Comparator: Curcumin Placebo
    Identical looking placebo of the active arm
    Intervention: Drug: Placebo
Publications *

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 20, 2017)
172
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • in clinical remission for at least 1 month, defined as Mayo bowel frequency subscore ≤ 1 and Mayo rectal bleeding subscore = 0 (Table 2).
  • a history of at least one flare with symptoms that required intervention within 24 months before screening
  • age ≥ 18
  • written informed consent obtained

Exclusion Criteria:

  • receipt of immunosuppressive drugs or corticosteroids within 60 days of screening
  • prior bowel surgery except appendectomy
  • with severe relapse (Mayo score 9-12) in the last 3 months
  • History or evidence of incompletely resected colonic mucosal dysplasia
  • on regular curcumin supplements or intake of curry in diet for ≥5 days each week
  • presence of infections (exclude simple infections such as influenza, etc.) or sepsis
  • pregnancy or lactating women
  • with a Mayo endoscopic subscore ≥2 on sigmoidoscopy or colonoscopy at baseline
  • allergic to curry-related products
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jessica CHING +852 35053524 jessicaching@cuhk.edu.hk
Contact: Kitty CHEUNG +852 26373260 kittyccy@cuhk.edu.hk
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03122613
Other Study ID Numbers  ICMJE CUR2
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
Plan to Share IPD: No
Responsible Party Siew Chien NG, Chinese University of Hong Kong
Study Sponsor  ICMJE Chinese University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Siew Ng, Prof. Chinese University of Hong Kong
PRS Account Chinese University of Hong Kong
Verification Date June 2019

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