Completed PHASE2 INTERVENTIONAL 2-arm NCT01366859

Nutritional Intervention in Children With Autism Using Whey Protein (Immunocal): Impact on Core Areas of Behavior

Nutritional Intervention Using Supplementation With Cysteine-Rich Whey Protein Isolate (Immunocal®) in Children With Autism: Effects in Core Areas of Behavior- A Randomized Double-Blind Study

Sponsor: Immunotec Inc.

Conditions Autism Spectrum Disorders

Interventions Rice Protein (Placebo) Whey Protein

Updated 6 times since 2017 Last updated: Nov 2, 2016 Started: May 31, 2011 Primary completion: Oct 31, 2016 Completion: Oct 31, 2016

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01366859, this PHASE2 trial focuses on Autism Spectrum Disorders and remains completed. Sponsored by Immunotec Inc., it has been updated 6 times since 2011, reflecting limited change activity. Mental health research at this phase helps define safety and dosing parameters for future study.

Status Flow

Change History

6 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE2
Sep 2024 — Sep 2025 [monthly]

Completed PHASE2
Jul 2024 — Sep 2024 [monthly]

Completed PHASE2
Jan 2021 — Jul 2024 [monthly]

Completed PHASE2
Jun 2018 — Jan 2021 [monthly]

Completed PHASE2

▶ Show 1 earlier version

Jan 2017 — Jun 2018 [monthly]

Completed PHASE2

First recorded

May 2011

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Immunotec Inc.
Nova Southeastern University

Data source: Nova Southeastern University

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Fort Lauderdale, United States