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Published on: July 31, 2017
The role of probiotics in children with autism spectrum disorders: A study protocol for a randomised controlled trial
Lingling Zhang1, Yiran Xu1, Hongwei Li1
1Henan Key Laboratory of Child Brain Injury and Henan Clinical Research Center for Child Neurological Disorders, Institute of Neuroscience and The Third Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Insights
This study investigates if probiotics can improve autism spectrum disorder (ASD) symptoms in children. Researchers will assess changes in microbiota, immunity, and metabolism to understand potential therapeutic effects for ASD.
Area of Science:
- Neuroscience
- Microbiology
- Pediatrics
Background:
- Autism spectrum disorder (ASD) is a lifelong neurodevelopmental condition with unclear etiology and limited treatment efficacy.
- Current treatments for ASD focus on education and rehabilitation, often showing minimal improvement in core symptoms.
- Emerging research suggests a link between gut microbiota and ASD, with probiotics showing potential to rebalance microbiota and alleviate symptoms.
Purpose of the Study:
- To evaluate the efficacy of probiotic supplementation in improving core symptoms of ASD in children.
- To explore the underlying mechanisms of probiotic action in ASD, including effects on immunity, metabolism, and the gut metagenome.
- To provide a scientific basis for the clinical application of probiotics as a therapeutic strategy for ASD.
Main Methods:
- A prospective, randomized controlled trial involving 160 children diagnosed with ASD.
- Participants will be stratified by ASD symptom severity and assigned to receive either probiotic supplements or a placebo for three months.
- Comprehensive evaluations using standardized scales and questionnaires will be conducted before, during, and after treatment, with follow-up assessments.
Main Results:
- Previous research indicated significant differences in gut flora abundance in children with ASD, with Bifidobacterium levels correlating with symptom severity.
- This study aims to confirm these findings and demonstrate the impact of probiotics on ASD symptoms and associated biological markers.
- The results are expected to elucidate the relationship between probiotics and ASD, offering insights into novel treatment approaches.
Conclusions:
- Probiotic supplementation may offer a viable therapeutic avenue for managing core symptoms of autism spectrum disorder.
- Further research into the gut-brain axis and microbiota modulation holds promise for developing effective interventions for ASD.
- This study will contribute valuable data to support the integration of probiotics into ASD management strategies.
Background:
Autism 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.
Objective:
The objectives of this study are to evaluate the efficacy of probiotics on the symptoms of children with ASD and the possible mechanisms involved.
Methods:
This 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 Registration:
This study has been registered with Chinese Clinical Trial Registry (ChiCTR-2000037941).
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