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

NCT ID: NCT06470412

Last Updated: 2025-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-02

Study Completion Date

2024-06-10

Brief Summary

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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

Detailed Description

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Conditions

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Autoimmune Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Control Group

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type 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

Group Type EXPERIMENTAL

AI-Guided Group

Intervention Type OTHER

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

Interventions

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Control group

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

Intervention Type OTHER

AI-Guided Group

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Triangel Scientific

INDUSTRY

Sponsor Role collaborator

Center of New Medical Technologies

OTHER

Sponsor Role collaborator

S.LAB (SOLOWAYS)

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Center of New Medical Technologies

Novosibirsk, Novosibisk Region, Russia

Site Status

Countries

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Russia

Other Identifiers

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SW015

Identifier Type: -

Identifier Source: org_study_id

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