AdiaVita and glutathione for autism in kids and teens

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 randomized, participant-blinded crossover trial enrolling about 100 individuals aged 3 and older with autism. Participants are assigned to three monthly infusions of AdiaVita plus glutathione or placebo saline with glutathione, followed by a potential crossover to the experimental treatment for eligible controls. The primary outcome is change in Autism Treatment Evaluation Checklist (ATEC) scores, with safety monitored for 12 months. The study is investigational and not FDA-approved for autism, and procedures include bloodwork and regular visits, conducted largely in the Atlanta area. Participants and families should note the cost of the initial treatment schedule and the importance of adherence to study visits and safety follow-up.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 3 years and up
* Confirmed ASD diagnosis (DSM-5 criteria, supported by ADOS-2 or its equivalent)
* Parent/guardian willingness to consider experimental treatments and comply with study requirements
* Ability to obtain required bloodwork
* Ability to attend all scheduled visits

Exclusion Criteria:

* Severe allergies to study products
* Significant uncontrolled medical conditions
* Immunocompromised
* Malignancy history
* Unstable medication regimen or inconsistent medication adherence (e.g., frequent medication changes or missed doses) within 30 days prior to Baseline, at Investigator discretion
* Pregnancy or breastfeeding (if applicable)
* Participation in another interventional trial within 30 days

Where it's running

• Greater Atlanta Integrative Pediatrics
  Roswell, Georgia, United States Recruiting
• Greater Atlanta Integrative Pediatrics
  Roswell, Georgia, United States Recruiting

Study contacts

• Principal investigator: Maia Gaither, MD — Greater Atlanta Integrative Pediatrics
• Study coordinator: Maia Gaither, MD
• Email: intakes@gaipeds.com
• Phone: 4047513693

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.