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

S

S.LAB (SOLOWAYS)

Status

Completed

Conditions

Autoimmune Diseases

Treatments

Other: AI-Guided Group
Other: Control group

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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

Enrollment

160 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

160 participants in 2 patient groups

Control Group
Active Comparator group
Treatment:
Other: Control group
AI-Guided Group
Experimental group
Treatment:
Other: AI-Guided Group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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