ArticlePloS one2022
The role of probiotics in children with autism spectrum disorders: A study protocol for a randomised controlled trial.
Article in PloS one, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
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Who cites it
14 citing papers in PubMed, 47 citations in OpenAlex.
- Towards treatments targeting the gut to improve behavioural outcomes in autism spectrum disorder.Journal of neural transmission (Vienna, Austria : 1996) · 2026Review
- Research progress on the microbiota-gut-brain axis in autism spectrum disorder: a narrative review.Frontiers in microbiology · 2026Review
- Gut dysbiosis in neurodevelopmental disorders: linking microbiota signatures to cognitive rigidity in autism spectrum disorder.Frontiers in microbiology · 2026Review
- The analysis of gut microbiota characteristics in children with global developmental delay.Frontiers in cellular and infection microbiology · 2025Article
- Progress in Probiotic Science: Prospects of Functional Probiotic-Based Foods and Beverages.International journal of food science · 2025Review
- Effect of dietary zinc supplementation on the gastrointestinal microbiome and host gene expression in theFrontiers in microbiology · 2025Article
- Melatonin AttenuatesInternational journal of molecular sciences · 2024Article
- Article
- Review
- Interconnection between Microbiota-Gut-Brain Axis and Autism Spectrum Disorder Comparing Therapeutic Options: A Scoping Review.Microorganisms · 2023Article
- The importance of comprehensive support based on the three pillars of exercise, nutrition, and sleep for improving core symptoms of autism spectrum disorders.Frontiers in psychiatry · 2023Review
- Role of the Gut-Brain Axis, Gut Microbial Composition, Diet, and Probiotic Intervention in Parkinson's Disease.Microorganisms · 2022Review
- Probiotics: Protecting Our Health from the Gut.Microorganisms · 2022Review
- Article
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Authors and funding
6 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAutism spectrum disorder (ASD) is a neurological and developmental condition that begins in infancy or earlier and lasts through the individual's lifetime. The aetiology and mechanisms of ASD are not yet fully understood, and current treatment comprises mainly education and rehabilitation, without significant improvement in the core symptoms. Recent studies suggest that microbiota change in children with ASD after the ingestion of probiotics may improve the balance of microbiota and thus ASD symptoms.
objectiveThe objectives of this study are to evaluate the efficacy of probiotics on the symptoms of children with ASD and the possible mechanisms involved.
methodsThis is a prospective controlled trial. A total of 160 children with ASD will be stratified and allocated to placebo and probiotics groups randomised according to the severity of their ASD symptoms. The probiotics group will be given probiotics supplements orally twice a day for 3 months and the control group will be given a placebo at the same amount, in addition to the baseline therapy of education and rehabilitation. All the children will be evaluated systematically by using different scales, questionnaires before, during, and after 3 months' treatment, as well as 3 months after discontinuation. The potential impact of probiotics on immunity and inflammation, metabolism, and metagenome will also be investigated. DISCUSSION: Our previous study showed that the abundance of intestinal flora was greatly different in children with ASD, and that Bifidobacterium was associated with the severity of ASD. In the present study, we will investigate the impact of probiotics supplementation on the symptoms of Children with ASD, with the purpose of evaluating the possible therapeutic effects of additives on ASD and of providing a reference for clinical treatment. The results will help to disclose as yet unknown relationship between probiotics and ASD.
trial registrationThis study has been registered with Chinese Clinical Trial Registry (ChiCTR-2000037941).
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