A Study of Curcumin (Soloways ™) in Patients With Inflammatory Bowel Disease Homozygous for the I… (NCT06867939) | Clinical Trial Compass
CompletedNot Applicable
A Study of Curcumin (Soloways ™) in Patients With Inflammatory Bowel Disease Homozygous for the IL-10 Variant
Russia40 participantsStarted 2024-05-05
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Clinical Disease Activity Index
Timeframe: 12 weeks
2
For Crohn's disease: Crohn's Disease Activity Index