Adia Med of Winter Park LLC Autism Spectrum Disorder Research Study

What Was Tested

The trial (phase 1) is built around Glutathione.

About 100 children with confirmed autism will be randomly assigned to one of two groups.

One group receives monthly IV AdiaVita plus IV glutathione for 3 months.

It had two arms (groups): Glutathione with Stem Cells (experimental) and Glutathione Only (active comparator).

The registry classes the interventions as biological and drug.

Who Took Part

Enrollment: 100 planned participants were the target.

It was open to people of any sex aged from 3 years up to 12 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age 3-12 years. Confirmed ASD diagnosis (DSM-5 criteria, supported by ADOS-2). Parent/guardian willingness to consider experimental treatments and comply with study requirements. Ability to attend all scheduled visits. Able to meet study cost requirements ($12,000 study fee plus bloodwork costs, if applicable) as described in the informed consent.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: severe allergies to study products; pregnancy or breastfeeding (if applicable); participation in another interventional trial within 30 days.

How the Study Was Run

The set-up was randomized, crossover and single-blind.

The participants were allocated by chance, so the Glutathione group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Glutathione and the comparison in turn, acting as their own control.

Only one side, usually the participants, was kept unaware of whether Glutathione was given.

Those kept unaware of assignments: participant.

It started in 2026-05-01 with completion listed for 2028-06-15.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change from Baseline in Total Autism Treatment Evaluation Checklist (ATEC) Score at Month 6 (time frame: Baseline and Month 6).

It also tracked 3 secondary outcomes, for example Change from Baseline in Total Autism Treatment Evaluation Checklist (ATEC) Score at Month 3, Change from Baseline in Total Autism Treatment Evaluation Checklist (ATEC) Score at Month 12 and Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Glutathione in 100 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glutathione compound page, all human trials.