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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Liposomal Curcumin, 400-600 mg/day taken orally for 12 weeks, plus standard of care.
Liposomal Curcumin, 400-600 mg/day taken orally for 12 weeks, plus standard of care.
Center for New Medical Technologies
Novosibirsk, Russia
Change in Clinical Disease Activity Index
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.
Time frame: 12 weeks
For Crohn's disease: Crohn's Disease Activity Index
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.
Time frame: 12 Weeks
Change in High-sensitivity C-Reactive Protein (hs-CRP) Concentration
Change in serum high-sensitivity C-reactive protein (hs-CRP) concentration (measured in mg/L) from baseline to 12 weeks. The outcome will be reported as the mean change in hs-CRP concentration.
Time frame: 12 weeks
Change in Fecal Calprotectin Concentration
Change in fecal calprotectin concentration (measured in µg/g) from baseline to 12 weeks will be assessed. The outcome will be reported as the mean change in fecal calprotectin concentration.
Time frame: 12 weeks
Change in Additional Cytokines TNF-α
Time frame: 12 weeks
Change in Additional Cytokines IL-1β
Time frame: 12 weeks
Adverse Events
Time frame: 12 weeks
Change in Patient-Reported Quality of Life as Measured by the Inflammatory Bowel Disease Questionnaire (IBDQ)
Description: Patient-reported quality of life will be assessed using the Inflammatory Bowel Disease Questionnaire (IBDQ). The IBDQ total score ranges from 32 to 224, where higher scores indicate a better quality of life. The outcome will be reported as the mean change in IBDQ total score from baseline to 12 weeks.
Time frame: 12 weeks
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