Curcumin for Prevention of Relapse in Patients With Ulcerative Colitis

Ulcerative Colitis in Remission Clinical Trial

Official title: A Double-blind, Randomized, Placebo-Controlled Trial of Curcumin Versus Placebo for Prevention of Relapse in Patients With Ulcerative Colitis

Status Terminated

Clinical Trial 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).

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis in Remission

• NCT number: NCT03122613
• Study type: Interventional
• Source: Chinese University of Hong Kong
• Status: Terminated
• Phase: N/A
• Start date: June 19, 2017
• Completion date: May 22, 2020