Taurine supplementation in children with autism spectrum disorders: a study protocol for an exploratory randomized, double-blind, placebo-controlled trial

BACKGROUND: ASD is the most common neurodevelopment dysfunction and disabling disorder in childhood, with a lack of specific clinical treatment methods. Evidence-based study reveals that nutrients supplement can improve the core symptom of ASD. Our previous study demonstrated the children with ASD were found to have lower taurine levels in serum and urine samples. However, whether or not the taurine supplementation can improve the core symptom of ASD is unclear. METHODS: This is an exploratory randomized, double-blind, placebo-controlled trial. Sixty children with ASD will be randomly allocated to receive daily taurine supplementation (taking orally with the recommended dose) or placebo in a 1:1 ratio for 3 months. All children will receive behavioral treatment throughout the study period. All researchers, participants and their caregivers will be blinded until the completion of data analysis, and randomization and allocation will be fully concealed from all mentioned parties. Follow-up will be conducted at the baseline, 1st month, 2nd month, 3rd month, 6th month, 9th month and 12th month. The primary outcomes will focus on changes in scores of ASD-specific questionnaires. DISCUSSION: To our knowledge there are no randomized controlled trials assessing the effects of daily taurine supplementation on the core symptoms of ASD. This trial would help evaluate the efficacy of taurine supplementation on ASD, and initially explore if its potential value on clinical application outweighs the risk. TRIAL REGISTRATIONS: ClinicalTrials Registry NCT05980520. Registered on July 31, 2023.