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

NCT06867939 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-04-11

No results posted yet for this study

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.

Conditions

  • Inflamatory Bowel Disease

Interventions

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.

Sponsors & Collaborators

  • S.LAB (SOLOWAYS)

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-05
Primary Completion
2024-09-20
Completion
2025-02-02

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06867939 on ClinicalTrials.gov