Curcumin Supplementation as an Add on Treatment for Patients With Inflammatory Bowel Diseases Treated With Vedolizumab
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Clinical remission- ulcerative colitis patients
研究概览
简要总结
Introduction: The pathogenesis of inflammatory bowel diseases (IBD) is characterized by dysregulation of the innate immune response it's associated with Th1, Th17 up-regulation, reflected by increased cytokine secretion including TNF-α. A main effective therapeutic interventions is blocking TNFα. Vedolizumab, an anti integrin, is a new class of treatment designed to block trafficking of lymphocytes in the gut. Clinical trials and real life experience response rates at week 6 range between 30-45%. Curcumin suppresses NFκβ levels via alteration of TLR2/4 pathways lowering TNF-α upstream. Curcumin is safe and efficacious in inducing response and remission in mild-moderate Ulcerative colitis (UC) and maintaining remission when used as an add-on to 5ASA derivatives, only with strict adherence to treatment overtime.
Objectives: Facing the low rate of response to therapies in IBD, the need for new treatments and the use of combination strategies lead us to believe that combining vedolizumab and curcumin may have a synergistic effect and will enable optimal immunomodulation.
Hypothesis: Concomitant oral curcumin in IBD patients with colonic involvement will augment remission rates as well as clinical and biochemical response.
Type of research and methods of data collection: A randomized controlled trial in 84 adults with colonic IBD (UC and CD). Eligible patients are during vedolizumab induction, patients will randomized will be into curcumin or placebo. Data will managed by investigators.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established inflammatory bowel disease
- •Age ≥18 years old
- •At inclusion all patients must have a documented active colonic involvement based on either endoscopy or imaging:
- •Commencing vedolizumab therapy according to the treating physician or on active therapy up to 6-weeks.
- •Active luminal disease:
- •CD- HBI ≥325, 26 UC- partial Mayo ≥227
- •Evident active disease on endoscopy or imaging within 2-week from inclusion or elevated inflammatory markers at screening (CRP> 0.5 mg/dl, or fecal calprotectin>100 μgr/gr stool or ESR >40).
排除标准
- •CD- isolated small bowel disease (L1) UC- proctitis (E1)
- •Perianal disease
- •Biliary obstruction
- •Concomitant treatment with beta blockers, anti-coagulants, and norfloxacin (relative contra indications to curcumin therapy).
- •Curcumin supplementations within the last 6 months.
结局指标
主要结局
Clinical remission- ulcerative colitis patients
时间窗: 52 weeks
Disease activity index - partial Mayo score less than 2
Clinical remission- Crohn's disease patients
时间窗: 52 weeks
Crohn's disease patients - disease activity indexe: Harvey Bradshow index (HBI) less that 3
次要结局
- Disease response- Crohn's disease patients(52 weeks)
- Disease response- ulcerative colitis patients(52 weeks)
- Biochemical remission(52 weeks)
研究者
Henit Yanai
Head of IBD center
Rabin Medical Center