NCT06867939

A Study of Curcumin (Soloways ™) in Patients With Inflammatory Bowel Disease Homozygous for the IL-10 Variant

A Pilot Study of Curcumin (Soloways ™) in Patients With Inflammatory Bowel Disease Homozygous for the IL-10 Variant

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: S.LAB (SOLOWAYS) · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Inflamatory Bowel Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	liposomal curcumin	Liposomal Curcumin, 400-600 mg/day taken orally for 12 weeks, plus standard of care.
DIETARY_SUPPLEMENT	Liposomal Curcumin	Liposomal Curcumin, 400-600 mg/day taken orally for 12 weeks, plus standard of care.

Timeline

• Start date: 2024-05-05
• Primary completion: 2024-09-20
• Completion: 2025-02-02
• First posted: 2025-03-10
• Last updated: 2025-04-11

Locations

1 site across 1 country: Russia