A Pilot Study of Curcumin (Soloways ™) in Patients With Inflammatory Bowel Disease Homozygous for the IL-10 Variant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Clinical Disease Activity Index
研究概览
简要总结
This pilot, genotype-stratified clinical trial aims to evaluate the safety and preliminary efficacy of liposomal curcumin in patients with inflammatory bowel disease (IBD) who are homozygous for a specific "unfavorable" IL-10 gene variant (e.g., rs1800896). The study will compare clinical and inflammatory markers in two cohorts: (1) homozygous carriers of the IL-10 variant and (2) non- carriers. The hypothesis is that curcumin supplementation will lead to more pronounced improvement in clinical activity scores and inflammatory biomarkers among homozygous carriers due to their inherently reduced anti-inflammatory capacity.
详细描述
Inflammatory bowel diseases (including Crohn's disease and ulcerative colitis) are characterized by chronic intestinal inflammation driven by a complex interplay of genetic, immune, and environmental factors. IL-10 plays a crucial role in anti-inflammatory pathways; certain genetic variants can reduce IL-10 production and predispose patients to more severe disease phenotypes.
Curcumin, a polyphenol derived from turmeric, has shown anti-inflammatory effects via multiple molecular targets, including NF-κB. However, curcumin's bioavailability is limited; liposomal formulations may enhance its absorption and therapeutic impact. This pilot trial examines whether liposomal curcumin provides a more significant clinical benefit specifically in patients with the homozygous IL-10 variant, as this subgroup may be particularly responsive to additional anti- inflammatory support.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Adults aged 18-70 years with a confirmed diagnosis of ulcerative colitis or Crohn's disease.
- •Stable background IBD treatment regimen (5-ASA, immunomodulators, or low-dose corticosteroids) for at least 4 weeks prior to enrollment.
- •Willingness to undergo genotyping for the IL-10 variant and to comply with the study protocol.
- •For the IL-10 Homozygous Variant Cohort: confirmed homozygous "unfavorable" variant (e.g., rs1800896) prior to enrollment.
- •For the Non-Variant Cohort: confirmed absence of the "unfavorable" allele (wild-type).
排除标准
- •Use of high-dose corticosteroids or biologics (e.g., TNF inhibitors) initiated within 4 weeks prior to enrollment.
- •Known allergy or hypersensitivity to curcumin or related compounds. Severe concomitant illness (significant liver or renal dysfunction, uncontrolled diabetes, etc.) that could interfere with interpretation of results or patient safety.
- •Pregnancy or breastfeeding.
- •Inability to provide informed consent or comply with study procedures.
研究组 & 干预措施
Non-Variant (Control) Cohort
干预措施: Liposomal Curcumin (Dietary Supplement)
IL-10 Homozygous Variant Cohort
干预措施: liposomal curcumin (Dietary Supplement)
结局指标
主要结局
Change in Clinical Disease Activity Index
时间窗: 12 weeks
Change in the Mayo Clinic Score from baseline to 12 weeks will be assessed for patients with ulcerative colitis. The Mayo Clinic Score is a composite index with four components (stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment), each rated 0 to 3, resulting in a total score ranging from 0 to 12. Higher scores indicate worse disease activity.
For Crohn's disease: Crohn's Disease Activity Index
时间窗: 12 Weeks
Change in the Crohn's Disease Activity Index (CDAI) from baseline to 12 weeks will be assessed for patients with Crohn's disease. The CDAI is calculated from multiple clinical variables and typically ranges from 0 to approximately 600, with higher scores indicating more active disease.
次要结局
- Adverse Events(12 weeks)
- Change in Additional Cytokines TNF-α(12 weeks)
- Change in High-sensitivity C-Reactive Protein (hs-CRP) Concentration(12 weeks)
- Change in Fecal Calprotectin Concentration(12 weeks)
- Change in Additional Cytokines IL-1β(12 weeks)
- Change in Patient-Reported Quality of Life as Measured by the Inflammatory Bowel Disease Questionnaire (IBDQ)(12 weeks)