Autoimmune DiseasesNCT06470412
Personalized Management of Autoimmune Diseases With AI-Guided (GenAIS TM) Dietary Supplementation
A study testing AI-Guided Group in people with Autoimmune Diseases, run by S.LAB (SOLOWAYS) at 1 site in Russia.
Trial summary
The study "Personalized Management of Autoimmune Diseases with AI-Guided (GenAIS TM) Dietary Supplementation" investigated the effectiveness of AI-guided dietary supplement (DS) prescriptions compared to standard physician-guided prescriptions in managing autoimmune diseases. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Autoimmune Diseases
- What is being tested?
- AI-Guided Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteRussia
- Study dates
- 2 Feb 2023to 10 Jun 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with an autoimmune disease (e.g., rheumatoid arthritis, lupus, multiple sclerosis) according to established clinical criteria.
- Moderate to severe disease activity as indicated by standardized measures (e.g., DAS28 for rheumatoid arthritis, SLEDAI for lupus).
- Stable on existing autoimmune medication regimen for at least 3 months prior to the study.
- Willingness to provide genetic and metabolic data.
- Written informed consent.
Who cannot join
- Current or past history of severe psychiatric conditions or other severe chronic diseases.
- Significant medical conditions like severe renal, hepatic, or cardiovascular diseases that may interfere with the study outcomes.
- Use of dietary supplements that affect immune function within the last 3 months.
- Pregnancy or breastfeeding.
- Recent changes in autoimmune medication within the last 3 months.
- Participation in another clinical trial within the last 30 days.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Center of New Medical Technologies
Novosibirsk, Novosibisk Region, 630090
About this study
Official title: Personalized Management of Autoimmune Diseases With AI-Guided (GenAIS TM) Dietary Supplementation: A Randomized Controlled Study
The study "Personalized Management of Autoimmune Diseases with AI-Guided (GenAIS TM) Dietary Supplementation" investigated the effectiveness of AI-guided dietary supplement (DS) prescriptions compared to standard physician-guided prescriptions in managing autoimmune diseases. This 6-month randomized controlled trial included 160 participants with conditions like rheumatoid arthritis, lupus, and multiple sclerosis. Participants were divided into two groups: one received DS based on physician judgment, and the other based on GenAIS AI system analysis. Primary outcomes focused on changes in disease activity, while secondary outcomes included quality of life, metabolic markers, and DS adherence. Data collection involved genetic, metabolic, and clinical profiling, with ethical considerations ensuring participant confidentiality and informed consent
- Conditions
- Autoimmune Diseases
- Being tested
- Control group, AI-Guided Group
- Keywords
- AI-guided dietary supplementation, Genetic profiling, Metabolic profiling, Disease reduction
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupOther
Participants receive supplement prescriptions from a physician based on current standard practices, which include biochemical markers, genetic data, and metabolic profiles.
AI-Guided GroupOther
Participants receive supplement prescriptions determined by GenAIS, an AI system which considers genetic data, metabolic profiles, biochemical markers, and patient history.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Not described Receives: Other: Control group |
| AI-Guided Group | Experimental | Not described Receives: Other: AI-Guided Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percent change in disease activity scores for the AI-Guided group compared with the Control group
Systemic Lupus Erythematosus Disease Activity Index, which has a score range from 0 to 105, to measure disease activity in participants with lupus.
Disease Activity Score 28 (DAS28), which has a score range from 0 to 10, to measure disease activity in participants with rheumatoid arthritis.
Measured: 6 months
Secondary outcomes (7)
Percent change in specific symptoms of autoimmune disease
Measured: 6 months
Percent change in high-sensitivity C-reactive protein
Measured: 6 months
Percent change in body weight and body mass index
Measured: 6 months
Incidence of adverse effects related to dietary supplements.
Measured: 6 months
Number Participant adherence to the prescribed dietary supplements regimen
Measured: 6 months
Changes in quality of life score Short Form-36
Short Form-36 Health Survey, which has a score range from 0 to 100, to measure the quality of life in participants, with higher scores indicating better health and well-being.
Measured: 6 months
Changes in quality of life score World Health Organization Quality of Life - BREF
World Health Organization Quality of Life - BREF, which has a score range from 0 to 100, to measure the quality of life in participants, with higher scores indicating better quality of life.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start2 Feb 2023
- Primary completion30 May 2024
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- S.LAB (SOLOWAYS)
- Sponsor type
- University, hospital or other
- Collaborators
- Triangel Scientific, Center of New Medical Technologies
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06470412
- Sponsor's protocol ID
- SW015
- Status last verified
- Jun 2024
- First submitted
- 17 Jun 2024
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- Personalized Management of Autoimmune Diseases With AI-Guided (GenAIS TM) Dietary Supplementation: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06470412
- Acronym / sponsor ID
- SW015
- Conditions
- Autoimmune Diseases
- Keywords
- AI-guided dietary supplementation, Genetic profiling, Metabolic profiling, Disease reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- S.LAB (SOLOWAYS)University, hospital or other
- Collaborators
- Triangel Scientific, Center of New Medical Technologies
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 24 Jun 2024 (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.
The study "Personalized Management of Autoimmune Diseases with AI-Guided (GenAIS TM) Dietary Supplementation" investigated the effectiveness of AI-guided dietary supplement (DS) prescriptions compared to standard physician-guided prescriptions in managing autoimmune diseases. This 6-month randomized controlled trial included 160 participants with conditions like rheumatoid arthritis, lupus, and multiple sclerosis. Participants were divided into two groups: one received DS based on physician judgment, and the other based on GenAIS AI system analysis. Primary outcomes focused on changes in disease activity, while secondary outcomes included quality of life, metabolic markers, and DS adherence. Data collection involved genetic, metabolic, and clinical profiling, with ethical considerations ensuring participant confidentiality and informed consent
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Control group |
| AI-Guided Group | Experimental | Other: AI-Guided Group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with an autoimmune disease (e.g., rheumatoid arthritis, lupus, multiple sclerosis) according to established clinical criteria.
- Moderate to severe disease activity as indicated by standardized measures (e.g., DAS28 for rheumatoid arthritis, SLEDAI for lupus).
- Stable on existing autoimmune medication regimen for at least 3 months prior to the study.
- Willingness to provide genetic and metabolic data.
- Written informed consent.
Key exclusion criteria (6 listed)
- Current or past history of severe psychiatric conditions or other severe chronic diseases.
- Significant medical conditions like severe renal, hepatic, or cardiovascular diseases that may interfere with the study outcomes.
- Use of dietary supplements that affect immune function within the last 3 months.
- Pregnancy or breastfeeding.
- Recent changes in autoimmune medication within the last 3 months.
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 |
|---|---|---|
| Control groupParticipants receive supplement prescriptions from a physician based on current standard practices, which include biochemical markers, genetic data, and metabolic profiles. | Other | Control Group |
| AI-Guided GroupParticipants receive supplement prescriptions determined by GenAIS, an AI system which considers genetic data, metabolic profiles, biochemical markers, and patient history. | Other | AI-Guided Group |
Primary outcome
The percent change in disease activity scores for the AI-Guided group compared with the Control group
Time frame: 6 months
Systemic Lupus Erythematosus Disease Activity Index, which has a score range from 0 to 105, to measure disease activity in participants with lupus. Disease Activity Score 28 (DAS28), which has a score range from 0 to 10, to measure disease activity in participants with rheumatoid arthritis.
7 secondary outcomes
Percent change in specific symptoms of autoimmune disease
Time frame: 6 months
Percent change in high-sensitivity C-reactive protein
Time frame: 6 months
Percent change in body weight and body mass index
Time frame: 6 months
Incidence of adverse effects related to dietary supplements.
Time frame: 6 months
Number Participant adherence to the prescribed dietary supplements regimen
Time frame: 6 months
Changes in quality of life score Short Form-36
Time frame: 6 months
Changes in quality of life score World Health Organization Quality of Life - BREF
Time frame: 6 months
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.
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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 AI-Guided Group in people with Autoimmune Diseases, 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 5 inclusion and 6 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?
The percent change in disease activity scores for the AI-Guided group compared with the Control group (time frame: 6 months). 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.