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NCT Number: NCT06470412

Personalized Management of Autoimmune Diseases With AI-Guided (GenAIS TM) Dietary Supplementation

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

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Key information

Conditions

Autoimmune Diseases Immune System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center of New Medical Technologies

Novosibirsk, Novosibisk Region, 630090, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Control Group

Other

Participants receive supplement prescriptions from a physician based on current standard practices, which include biochemical markers, genetic data, and metabolic profiles.

AI-Guided Group

Other

Participants receive supplement prescriptions determined by GenAIS, an AI system which considers genetic data, metabolic profiles, biochemical markers, and patient history.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Percent change in specific symptoms of autoimmune disease

    Time frame: 6 months

  2. Percent change in high-sensitivity C-reactive protein

    Time frame: 6 months

  3. Percent change in body weight and body mass index

    Time frame: 6 months

  4. Incidence of adverse effects related to dietary supplements.

    Time frame: 6 months

  5. Number Participant adherence to the prescribed dietary supplements regimen

    Time frame: 6 months

  6. Changes in quality of life score Short Form-36

    Time frame: 6 months

    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.

  7. Changes in quality of life score World Health Organization Quality of Life - BREF

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

S.LAB (SOLOWAYS)

Other

Collaborators

  • Center of New Medical Technologies
  • Triangel Scientific

Registry information

Official study title

Personalized Management of Autoimmune Diseases With AI-Guided (GenAIS TM) Dietary Supplementation: A Randomized Controlled Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 24, 2024
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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