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.

Study on the Treatment of Taurine in Children With Autism

Autism Spectrum Disorder

Autism spectrum disorders (ASD) are the most common disabling disorders in childhood and are
      characterized by social difficulties, stereotyped behavior, narrow interests and paresthesia.
      In recent years, the prevalence of ASD has been increasing year by year, and the latest
      epidemiology in the United States shows that the prevalence of ASD is 1/44. The previous
      multi-center epidemiological survey of ASD in children in China showed that the prevalence of
      ASD in children aged 6-12 in China was about 0.7%, and the lifetime medical and non-medical
      expenses of ASD patients ranged from $1.4 million to $2.4 million. The survey showed that the
      disease burden of ASD in children aged 0-6 in Guizhou Province was between 60,000 and 80,000
      yuan/year/person. ASD has become a major public health problem affecting children's health
      due to its high prevalence rate, disability rate and heavy disease burden, which has brought
      huge economic and social burden to families and society of children with ASD. At present, ASD
      has been listed as the leading disabling disease among mental diseases, bringing serious
      burden to families and society, and ASD has become a major public health problem affecting
      children's health.

      At present, there are no specific drugs to improve the core symptoms of ASD, and education
      and behavioral therapy are mainly focused on early intervention to obtain the best results.
      Although effective behavioral interventions can significantly improve the core symptoms of
      children with ASD, a significant proportion of children with ASD still have residual
      functional disabilities. Therefore, the research and development of new treatment methods for
      children with ASD has become a hot and difficult problem. Children with ASD are prone to
      multiple nutrients due to poor eating habits, gastrointestinal symptoms and food allergies,
      and the addition of key nutrients is expected to become one of the important adjuvant
      treatments for children with ASD. The project team established a national children's ASD
      multi-center research cohort and built a children's ASD biobank under the financial support
      of the National Health Commission. A case-control (117:119) study using 1H-NMR metabolomics
      to detect urine samples of children with ASD showed lower taurine levels in the ASD group
      compared to the healthy control group. In recent years, taurine deficiency has been linked to
      neurological disorders or symptoms such as neurodegenerative diseases, stroke, epilepsy, and
      diabetic neuropathy. In addition, animal and clinical experiments have found that taurine
      supplementation has certain therapeutic effects on neurological diseases including Angelman
      behavior sign, fragile X behavior sign, sleep-wake disorder, stroke, attention deficit
      hyperactivity disorder, tic disorder, and taurine supplementation can improve anxiety
      symptoms and cognitive ability of mice. In previous animal intervention experiment, taurine
      supplementation on the basis of VPA autism model in rats during pregnancy was found to
      improve ASD-like behavior in offspring. However, there is a lack of population-based evidence
      in children with ASD.

      Taurine is widely distributed in brain, spinal cord, heart, muscle cells and retina, and is
      one of the more abundant amino acids in almost all tissues and organs. A large number of
      studies have shown that taurine can protect a variety of tissues and organs from oxidative
      stress damage. Taurine can also ameliorate cognitive impairment in a variety of physiological
      and pathological conditions through a variety of mechanisms, including reducing
      neuroinflammation, up-regulating Nrf2 expression and antioxidant capacity, activating
      Akt/CREB/PGC1α signaling pathway to further enhance mitochondrial biosynthesis, synaptic
      function, and reducing oxidative stress. A large number of studies have shown that compared
      with healthy controls, the blood levels of oxidative stress markers in children with ASD are
      reduced or increased to varying degrees, and are thought to be related to the formation of
      stereotypical behaviors of ASD. Whether taurine can improve the core symptoms of ASD by
      reducing oxidative stress damage remains unclear, and human studies are needed to further
      clarify the mechanism of action and verify the findings of animal experiments.

      In summary, taurine deficiency is closely related to the onset of neurodevelopmental
      disorders, and dietary supplementation may have a certain therapeutic effect. This study is
      based on this starting point to propose the basis of project. This study intends to conduct
      an exploratory randomized, double-blind controlled trial to compare and analyze the effect of
      taurine supplementation on the improvement of core symptoms in ASD children who were treated
      with routine behavioral rehabilitation combined with taurine supplement (experimental group)
      and behavioral rehabilitation combined with placebo (control group) for 3 months and
      continued follow-up for 12 months. The possible mechanism of action was investigated by
      detecting intestinal symptoms, intestinal flora, markers of oxidative stress and clinical
      symptoms of ASD. The aim of this study is to explore an effective and reliable adjuvant
      therapy for children with ASD. To investigate the curative effect of taurine supplementation
      on the core symptoms of children with ASD spectrum disorder. To observe the incidence of
      adverse reactions of taurine supplementation, evaluate the clinical application value of
      taurine supplementation, and provide theoretical support for further tests.

Taurine+corn starch+white sugar

Corn starch+white sugar

Behavioral rehabilitation therapy

Taurine Supplementation Improves Core Symptoms in Children With Autism Spectrum Disorders: a Randomized, Double-blinded, Controlled Trial

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.

The Childhood Autism Rating Scale (CARS) developed by Schoplen(1980).The total score is 60 points, and CARS will be evaluated by clinicians. Participants with a score15-30,31-36,37-60 are considered as mild autism, moderate autism, severe autism.

6-item Gastrointestinal Severity Index(6-GSI) will be used to assess the Gastrointestinal syndromes of ASD patients, including constipation, diarrhea, average stool consistency, stool smell, flatulence, abdominal pain. The higher the score, the more severe the syndromes.

The Autism Spectrum Rating Scales (ASRS), consisting of 71 questions, consists of three core parts: defects in the nature of social interaction, abnormalities in language and communication, stereotypes, limitations, and repetitive interests and behaviors.
ASRS will be self-assessed by guardians. The ASRS questionnaire uses a 5-level score: 0 = never, meaning that it has never happened; 1 point = very few, refers to 1 or 2 times in a month; 2 points = sometimes, refers to 1 or 2 times in a week; 3 points = frequent, meaning 3 or 4 times in a week; 4 points = always, which means every day.

Social Responsiveness Scale (SRS), which quantifies children's social ability, are used to assess children's social ability. SRS will be self-assessed by guardians. There are five subscales: Social Awareness, Social Cognition, Social Communication and Social motivation And Autistic Mannerisms. The main feature of this scale is to evaluate the social situation of children closely with social disorder as the core symptom of ASD.

Identification and Management of Feeding Difficulties(IMFeD), it is composed of 17 items and contains six dimensions: poor appetite, particular food preferences, poor eating habits, excessive parental concern, fear of eating, and underlying disease status. IMFeD will be self-assessed by guardians. The severity of children's eating behavior problems is divided into four levels: "Always" refers to an average of 5 or more days per week when the eating behavior or feeling."Often" means having this behavior or feeling on average 3 to 4 days per week."Sometimes" means having this behavior or feeling on average 1 to 2 days per week."Never" means that the action or feeling does not occur.

The Gesell developmental scale mainly assesses the function of the central nervous system. It has five specific domains, gross motor, fine motor, language and individual-social behavior. Gesell Developmental Scale will be evaluated by clinicians.According to the relationship between the scores obtained in 5 behavioral fields and actual age, the development quotient(DQ) of each field was calculated. Edge state: 76≤DQ≤85; Mild stunting: 55≤DQ≤75; Moderate stunting: 40≤DQ≤54; Severe stunting: 25≤DQ≤39; Very severe stunting: DQ<25.

Children's Sleep Habits Questionnaire (CSHQ), which contains 48 items, can detect eight specific sleep problems, such as bad sleeping habits, sleep anxiety, irregular sleep duration, sleep disordered breathing, abnormal sleep, daytime sleepiness, night waking, and prolonged sleep latency. CSHQ will be self-assessed by guardians. The CSHQ asked parents to recall their children's sleep conditions in the past four weeks, and rated the children's sleep conditions as "often" (5-7 times per week), "sometimes" (2-4 times per week), and "rarely or none" (0-1 times per week).

Height(cm) and weight(kg) will be measured at each visit. BMI will be calculated as weight(kg)/[(height(cm)/100)^2 ]. Z score of BMI for age and gender will be computed based on the current national reference (2020).

Taurine combined with behavioral rehabilitation therapy

Placebo combined with behavioral rehabilitation therapy

Study on the Treatment of Taurine in Children With Autism

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

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