Curcumin for Prevention of Relapse in Patients With Ulcerative Colitis

NCT03122613 | Terminated DMC

• 1 other identifier: CUR2
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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).

Conditions

Ulcerative Colitis in Remission

Outcome Measures

Primary Outcomes (1)

• The relapse rate at 12 months

  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).

  1 year

Secondary Outcomes (8)

• Adverse events

  1 year

• Endoscopic remission

  1 year

• Simple Clinical Colitis Activity Index (SCCAI)

  1 year

• Fecal calprotectin levels at 12 months

  1 year

• Fecal immunochemical test (FIT) at 12 months

  1 year

Study Arms (2)

Curcumin

ACTIVE COMPARATOR

Dietary supplements of Curcumin capsules

Dietary Supplement: Curcumin

Curcumin Placebo

PLACEBO COMPARATOR

Identical looking placebo of the active arm

Drug: Placebo

Interventions

Curcumin DIETARY_SUPPLEMENT

3g of Curcumin per day

Also known as: Turmeric

Curcumin

Placebo DRUG

3g of Curcumin Placebo per day

Also known as: Curcumin placebo

Curcumin Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, 0000, Hong Kong

Location

Related Publications (11)

• Dignass A, Lindsay JO, Sturm A, Windsor A, Colombel JF, Allez M, D'Haens G, D'Hoore A, Mantzaris G, Novacek G, Oresland T, Reinisch W, Sans M, Stange E, Vermeire S, Travis S, Van Assche G. Second European evidence-based consensus on the diagnosis and management of ulcerative colitis part 2: current management. J Crohns Colitis. 2012 Dec;6(10):991-1030. doi: 10.1016/j.crohns.2012.09.002. Epub 2012 Oct 3. No abstract available.

  PMID: 23040451 BACKGROUND

• Feagan BG, Macdonald JK. Oral 5-aminosalicylic acid for maintenance of remission in ulcerative colitis. Cochrane Database Syst Rev. 2012 Oct 17;10:CD000544. doi: 10.1002/14651858.CD000544.pub3.

  PMID: 23076890 BACKGROUND

• Kane S, Huo D, Aikens J, Hanauer S. Medication nonadherence and the outcomes of patients with quiescent ulcerative colitis. Am J Med. 2003 Jan;114(1):39-43. doi: 10.1016/s0002-9343(02)01383-9.

  PMID: 12543288 BACKGROUND

• Kane SV, Cohen RD, Aikens JE, Hanauer SB. Prevalence of nonadherence with maintenance mesalamine in quiescent ulcerative colitis. Am J Gastroenterol. 2001 Oct;96(10):2929-33. doi: 10.1111/j.1572-0241.2001.04683.x.

  PMID: 11693328 BACKGROUND

• Sewitch MJ, Abrahamowicz M, Barkun A, Bitton A, Wild GE, Cohen A, Dobkin PL. Patient nonadherence to medication in inflammatory bowel disease. Am J Gastroenterol. 2003 Jul;98(7):1535-44. doi: 10.1111/j.1572-0241.2003.07522.x.

  PMID: 12873575 BACKGROUND

• Leong RW, Lawrance IC, Ching JY, Cheung CM, Fung SS, Ho JN, Philpott J, Wallace AR, Sung JJ. Knowledge, quality of life, and use of complementary and alternative medicine and therapies in inflammatory bowel disease: a comparison of Chinese and Caucasian patients. Dig Dis Sci. 2004 Oct;49(10):1672-6. doi: 10.1023/b:ddas.0000043384.26092.f4.

  PMID: 15573925 BACKGROUND

• Bernstein CN. Treatment of IBD: where we are and where we are going. Am J Gastroenterol. 2015 Jan;110(1):114-26. doi: 10.1038/ajg.2014.357. Epub 2014 Dec 9.

  PMID: 25488896 BACKGROUND

• Hilsden RJ, Verhoef MJ, Rasmussen H, Porcino A, DeBruyn JC. Use of complementary and alternative medicine by patients with inflammatory bowel disease. Inflamm Bowel Dis. 2011 Feb;17(2):655-62. doi: 10.1002/ibd.21360.

  PMID: 20848543 BACKGROUND

• Rawsthorne P, Clara I, Graff LA, Bernstein KI, Carr R, Walker JR, Ediger J, Rogala L, Miller N, Bernstein CN. The Manitoba Inflammatory Bowel Disease Cohort Study: a prospective longitudinal evaluation of the use of complementary and alternative medicine services and products. Gut. 2012 Apr;61(4):521-7. doi: 10.1136/gutjnl-2011-300219. Epub 2011 Aug 11.

  PMID: 21836028 BACKGROUND

• Gupta SC, Kismali G, Aggarwal BB. Curcumin, a component of turmeric: from farm to pharmacy. Biofactors. 2013 Jan-Feb;39(1):2-13. doi: 10.1002/biof.1079. Epub 2013 Jan 22.

  PMID: 23339055 BACKGROUND

• Vecchi Brumatti L, Marcuzzi A, Tricarico PM, Zanin V, Girardelli M, Bianco AM. Curcumin and inflammatory bowel disease: potential and limits of innovative treatments. Molecules. 2014 Dec 16;19(12):21127-53. doi: 10.3390/molecules191221127.

  PMID: 25521115 BACKGROUND

MeSH Terms

Interventions

Curcumin

Intervention Hierarchy (Ancestors)

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

Study Officials

• Siew Ng, Prof.

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blinded using identical looking products in both arms
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: April 21, 2017
• Study Start: June 19, 2017
• Primary Completion: May 22, 2020
• Study Completion: May 22, 2020
• Last Updated: October 17, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)