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

NCT ID: NCT06867939

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-05
• Study Completion Date: 2025-02-02

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IL-10 Homozygous Variant Cohort

Group Type: EXPERIMENTAL

liposomal curcumin

Intervention Type: DIETARY_SUPPLEMENT

Liposomal Curcumin, 400-600 mg/day taken orally for 12 weeks, plus standard of care.

Non-Variant (Control) Cohort

Group Type: ACTIVE_COMPARATOR

Liposomal Curcumin

Intervention Type: DIETARY_SUPPLEMENT

Liposomal Curcumin, 400-600 mg/day taken orally for 12 weeks, plus standard of care.

Interventions

liposomal curcumin

Liposomal Curcumin, 400-600 mg/day taken orally for 12 weeks, plus standard of care.

Intervention Type: DIETARY_SUPPLEMENT

Liposomal Curcumin

Liposomal Curcumin, 400-600 mg/day taken orally for 12 weeks, plus standard of care.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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. 5. For the Non-Variant Cohort: confirmed absence of the "unfavorable" allele (wild-type).

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

S.LAB (SOLOWAYS)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Center for New Medical Technologies

Novosibirsk, , Russia

Countries

Russia

Other Identifiers

SW019

Identifier Type: -

Identifier Source: org_study_id