Study on the Treatment of Taurine in Children With Autism

NCT05980520 | Completed DMC

• 1 other identifier: 20230702
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

In the treatment of autism spectrum disorders (ASD), medication is only an adjunct, and the main treatment modalities are education and behavioral therapy. People with autism incur huge medical and educational costs, which puts a great financial burden on families.Taurine is one of the abundant amino acids in tissues and organs, and plays a variety of physiological and pharmacological functions in nervous, cardiovascular, renal, endocrine and immune systems. A large number of studies have shown that taurine can improve cognitive function impairment under various physiological or pathological conditions through a variety of mechanisms, taurine can increase the abundance of beneficial bacteria in the intestine, inhibit the growth of harmful bacteria, and have a positive effect on intestinal homeostasis. This study intends to analyze the effect of taurine supplementation on ASD, and explore the possible mechanism by detecting intestinal symptoms, intestinal flora, markers of oxidative stress and clinical symptoms of ASD.

Conditions

Autism Spectrum Disorder

Keywords

autism spectrum disorders; children; taurine

Outcome Measures

Primary Outcomes (1)

• Score of Autism Treatment Evaluation Checklist (ATEC)

  Autism Treatment Evaluation Checklist (ATEC) will be used to evaluate the rehabilitation of ASD core syndromes after interventions, which includes communication, social, perception skills and healthy behaviors. ATEC will be self-assessed by guardians.Severity grading: mild (initial ATEC score 20-49), moderate (initial ATEC score 50-79), severe (initial ATEC score \>80). The lower the ATEC scores, the better the rehabilitation.

  From baseline till the 3th month.

Secondary Outcomes (9)

• Score of Autism Treatment Evaluation Checklist (ATEC)

  From baseline till the 1st,2rd,6th,9th,12th month.

• Childhood Autism Rating Scale(CARS)

  At the 3rd,6th,9th,12th month from baseline.

• 6-item Gastrointestinal Severity Index(6-GSI)

  At the1st,2rd,3rd,6th,9th,12th month from baseline.

• Autism Spectrum Rating Scales(ASRS)

  At the1st,2rd,3rd,6th,9th,12th month from baseline.

• Social Responsiveness Scale(SRS)

  At the1st,2rd,3rd,6th,9th,12th month from baseline.

Other Outcomes (3)

• Change of hemoglobin concentration in cortical metabolism

  At the 3rd month from baseline.

• Change of taurine-related serum metabolites levels

  At the 3rd month from baseline.

• Difference in proportions of Intestinal flora species(%)

  At the 3rd month from baseline.

Study Arms (2)

Taurine treatment group

EXPERIMENTAL

Taurine combined with behavioral rehabilitation therapy

Dietary Supplement: Taurine+corn starch+white sugar; Behavioral: Behavioral rehabilitation therapy

Placebo group

PLACEBO COMPARATOR

Placebo combined with behavioral rehabilitation therapy

Dietary Supplement: Corn starch+white sugar; Behavioral: Behavioral rehabilitation therapy

Interventions

Taurine+corn starch+white sugar DIETARY_SUPPLEMENT

Taurine granules mixed with corn starch and white sugar, 0.4g in 1 bag, taken orally. One time dosage: 1 bag each time for 1-2 years old, 3 times a day, 1.5 bags each time for 3-5 years old, 3 times a day, 2 bags each time for 6-8 years old, 3 times a day, 2.5-3 bags each time for 9-13 years old, 3 to 4 bags each time for children and adults over 14 years old, 3 times a day. The use of taurine is strictly in accordance with the specifications of Chinese Pharmacopoeia.

Taurine treatment group

Corn starch+white sugar DIETARY_SUPPLEMENT

0.4g in 1 bag, taken orally. One time dosage: 1 bag each time for 1-2 years old, 3 times a day, 1.5 bags each time for 3-5 years old, 3 times a day, 2 bags each time for 6-8 years old, 3 times a day, 2.5-3 bags each time for 9-13 years old, 3 to 4 bags each time for children and adults over 14 years old, 3 times a day.

Placebo group

Behavioral rehabilitation therapy BEHAVIORAL

Structured training courses which included: visual arrangement, routine, environmental arrangement, program schedule, personal work system consists of five parts. The course is designed and implemented by qualified behavioral rehabilitators who have worked for more than 5 years, with the participation of parents. The daily training time is about 6-8 hours, and the total intervention time is not less than 40 hours per week.

Placebo group; Taurine treatment group

Eligibility Criteria

• Age: 30 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Aged 2.5-18 years at enrollment.
• Meet the diagnosis criteria of ASD by the diagnostic and statistical manual of mental disorders(DSM-5).

You may not qualify if:

• Rett behavioral sign, cerebral palsy, other congenital diseases, associated with other inherited metabolic behavioral signs, epilepsy.
• Children who have had an acute or chronic infectious disease in the past 3 months.
• Children with abnormal liver and kidney function, chronic pulmonary heart disease.
• Children who have taken taurine supplements or medications in the past 3 months.
• Parents or patients refuse to participate in the study.
• The investigator determines that the subject is unable to comply with the study requirements.

Sponsors & Collaborators

• Guizhou Provincial People's Hospital: lead

Study Sites (1)

Guizhou Provincial People's Hospital

Guiyang, Guizhou, 550003, China

Location

Related Publications (1)

• Chen Y, He W, Deng Q, Peng Z, Tai Z, Ma Y, Wang T, Wang Y, Yan W, Zhou H. Taurine supplementation in children with autism spectrum disorders: a study protocol for an exploratory randomized, double-blind, placebo-controlled trial. BMC Pediatr. 2025 Oct 27;25(1):871. doi: 10.1186/s12887-025-06216-0.

  PMID: 41146076 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Hao Zhou

  Guizhou Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 8, 2023
• Study Start: August 18, 2023
• Primary Completion: June 20, 2024
• Study Completion: February 28, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)