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

Researchers are planning a study to test whether taurine supplements can help children with autism. Sixty children will either get taurine supplements or fake pills for 3 months, and researchers will track their progress for a full year. Previous research found that children with autism have lower taurine levels in their blood and urine. This would be the first proper scientific trial to test if taurine supplements actually help with autism symptoms.

This study protocol describes a planned randomized controlled trial investigating taurine supplementation in 60 children with autism spectrum disorder (ASD). The trial is designed as a double-blind, placebo-controlled study where participants will receive either daily taurine supplements or placebo for 3 months, with follow-up extending to 12 months. The research is motivated by previous findings showing lower taurine levels in children with ASD. Primary outcomes will measure changes in ASD-specific questionnaire scores.

All participants will continue receiving behavioral treatment throughout the study period. This represents the first randomized controlled trial specifically examining taurine supplementation effects on core ASD symptoms.

If effective, taurine supplementation could provide a low-risk nutritional intervention for ASD symptoms. However, evidence remains preliminary pending trial completion. The biological rationale based on observed taurine deficiency provides foundation for investigation, but clinical efficacy remains unproven.

This is a study protocol only - no actual results are reported. Small sample size of 60 participants may limit statistical power. The abstract does not specify taurine dosage or provide details about outcome measures beyond 'ASD-specific questionnaires.'

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.

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. 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.

ClinicalTrials Registry NCT05980520. Registered on July 31, 2023.