Inflamatory Bowel DiseaseNCT06867939
A Study of Curcumin (Soloways ™) in Patients With Inflammatory Bowel Disease Homozygous for the IL-10 Variant
A study testing liposomal curcumin in people with Inflamatory Bowel Disease, run by S.LAB (SOLOWAYS) at 1 site in Russia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Inflamatory Bowel Disease
- What is being tested?
- liposomal curcumin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteRussia
- Study dates
- 5 May 2024to 2 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Curcumin (Soloways ™) in Patients With Inflammatory Bowel Disease Homozygous for the IL-10 Variant
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.
Read the 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
- Being tested
- liposomal curcumin
- Keywords
- inflamatory bowel, inflammation, Interleukins, IL-10, supplements, curcumin
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liposomal curcuminDietary supplement
Liposomal Curcumin, 400-600 mg/day taken orally for 12 weeks, plus standard of care.
Liposomal CurcuminDietary supplement
Liposomal Curcumin, 400-600 mg/day taken orally for 12 weeks, plus standard of care.
| Study group | Role | What they receive |
|---|---|---|
| IL-10 Homozygous Variant Cohort | Experimental | Not described Receives: Dietary Supplement: liposomal curcumin |
| Non-Variant (Control) Cohort | Active comparator | Not described Receives: Dietary Supplement: Liposomal Curcumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 Weeks
Secondary outcomes (6)
Change in High-sensitivity C-Reactive Protein (hs-CRP) Concentration
Change in serum high-sensitivity C-reactive protein (hs-CRP) concentration (measured in mg/L) from baseline to 12 weeks. The outcome will be reported as the mean change in hs-CRP concentration.
Measured: 12 weeks
Change in Fecal Calprotectin Concentration
Change in fecal calprotectin concentration (measured in µg/g) from baseline to 12 weeks will be assessed. The outcome will be reported as the mean change in fecal calprotectin concentration.
Measured: 12 weeks
Change in Additional Cytokines TNF-α
Measured: 12 weeks
Change in Additional Cytokines IL-1β
Measured: 12 weeks
Adverse Events
Measured: 12 weeks
Change in Patient-Reported Quality of Life as Measured by the Inflammatory Bowel Disease Questionnaire (IBDQ)
Description: Patient-reported quality of life will be assessed using the Inflammatory Bowel Disease Questionnaire (IBDQ). The IBDQ total score ranges from 32 to 224, where higher scores indicate a better quality of life. The outcome will be reported as the mean change in IBDQ total score from baseline to 12 weeks.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start5 May 2024
- Primary completion20 Sep 2024
- Study completion2 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflamatory Bowel DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- S.LAB (SOLOWAYS)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867939
- Sponsor's protocol ID
- SW019
- Status last verified
- Mar 2025
- First submitted
- 20 Feb 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Curcumin (Soloways ™) in Patients With Inflammatory Bowel Disease Homozygous for the IL-10 Variant
- ClinicalTrials.gov ID
- NCT06867939
- Acronym / sponsor ID
- SW019
- Conditions
- Inflamatory Bowel Disease
- Keywords
- inflamatory bowel, inflammation, Interleukins, IL-10, supplements, curcumin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- S.LAB (SOLOWAYS)University, hospital or other
- Study start
- 5 May 2024 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 2 Feb 2025 (actual)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IL-10 Homozygous Variant Cohort | Experimental | Dietary Supplement: liposomal curcumin |
| Non-Variant (Control) Cohort | Active comparator | Dietary Supplement: Liposomal Curcumin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liposomal curcuminLiposomal Curcumin, 400-600 mg/day taken orally for 12 weeks, plus standard of care. | Dietary supplement | IL-10 Homozygous Variant Cohort |
| Liposomal CurcuminLiposomal Curcumin, 400-600 mg/day taken orally for 12 weeks, plus standard of care. | Dietary supplement | Non-Variant (Control) Cohort |
Primary outcome
Change in Clinical Disease Activity Index
Time frame: 12 weeks
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.
For Crohn's disease: Crohn's Disease Activity Index
Time frame: 12 Weeks
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.
6 secondary outcomes
Change in High-sensitivity C-Reactive Protein (hs-CRP) Concentration
Time frame: 12 weeks
Change in Fecal Calprotectin Concentration
Time frame: 12 weeks
Change in Additional Cytokines TNF-α
Time frame: 12 weeks
Change in Additional Cytokines IL-1β
Time frame: 12 weeks
Adverse Events
Time frame: 12 weeks
Change in Patient-Reported Quality of Life as Measured by the Inflammatory Bowel Disease Questionnaire (IBDQ)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing liposomal curcumin in people with Inflamatory Bowel Disease, run by S.LAB (SOLOWAYS) at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinical Disease Activity Index (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.