Clinical trial NCT06867939: A Study of Curcumin (Soloways ™) in Patients With Inflammatory Bowel Disease Homozygous for the IL-10 Variant
Official title: A Pilot Study of Curcumin (Soloways ™) in Patients With Inflammatory Bowel Disease Homozygous for the IL-10 Variant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflamatory Bowel Disease
Keywords: inflamatory bowel
inflammation
Interleukins
IL-10
supplements
curcumin
Lead sponsor: S.LAB (SOLOWAYS)
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Clinical Disease Activity Index
timeFrame: 12 weeks
measure: For Crohn's disease: Crohn's Disease Activity Index
timeFrame: 12 Weeks
Secondary outcomes:
measure: Change in High-sensitivity C-Reactive Protein (hs-CRP) Concentration
timeFrame: 12 weeks
measure: Change in Fecal Calprotectin Concentration
timeFrame: 12 weeks
measure: Change in Additional Cytokines TNF-α
timeFrame: 12 weeks
measure: Change in Additional Cytokines IL-1β
timeFrame: 12 weeks
measure: Adverse Events
timeFrame: 12 weeks
measure: Change in Patient-Reported Quality of Life as Measured by the Inflammatory Bowel Disease Questionnaire (IBDQ)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Center for New Medical Technologies
Study officials:
References: