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

NCT06867939 | Completed DMC

• 1 other identifier: SW019
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflamatory Bowel Disease

Keywords

inflamatory bowel; inflammation; Interleukins; IL-10; supplements; curcumin

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 Weeks

Secondary Outcomes (6)

• Change in High-sensitivity C-Reactive Protein (hs-CRP) Concentration

  12 weeks

• Change in Fecal Calprotectin Concentration

  12 weeks

• Change in Additional Cytokines TNF-α

  12 weeks

• Change in Additional Cytokines IL-1β

  12 weeks

• Adverse Events

  12 weeks

Study Arms (2)

IL-10 Homozygous Variant Cohort

EXPERIMENTAL

Dietary Supplement: liposomal curcumin

Non-Variant (Control) Cohort

ACTIVE COMPARATOR

Dietary Supplement: Liposomal Curcumin

Interventions

Liposomal Curcumin DIETARY_SUPPLEMENT

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

IL-10 Homozygous Variant Cohort

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• S.LAB (SOLOWAYS): lead

Study Sites (1)

Center for New Medical Technologies

Novosibirsk, Russia

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: March 10, 2025
• Study Start: May 5, 2024
• Primary Completion: September 20, 2024
• Study Completion: February 2, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)