Exploring gut microbiome and nutritional status among children with Autism Spectrum Disorder (MY-ASD Microbiome): A study protocol.

Malaysian researchers are planning a study to compare gut bacteria between 40 autistic boys and 40 non-autistic boys aged 4-10. They want to understand if differences in gut bacteria are linked to autism and eating problems. The study will collect saliva and stool samples to examine bacteria, plus measure nutrition, eating habits, and autism severity. This is just the study plan - no results are available yet.

The research aims to better understand autism and potentially improve nutrition support.

This is a study protocol for an observational case-control study in Malaysia examining gut and oral microbiome differences between 40 male children with autism (aged 4-10) and 40 typically developing controls. The MY-ASD Microbiome study aims to identify microbiota profiles through metagenomic sequencing of saliva and fecal samples, and explore associations with nutritional status, eating behaviors, and autism severity. The research addresses previous findings of gut dysbiosis in autism and feeding difficulties common in autistic children. Secondary objectives include examining relationships between microbiota and malnutrition risk.

Data collection is expected to complete by June 2026, with analyses planned using various statistical methods including mixed-effects logistic regression.

No clinical implications can be determined as this is a protocol paper without results. Future findings may inform understanding of microbiome-autism relationships and guide personalized nutrition interventions for autistic children, particularly regarding malnutrition risk assessment and early intervention strategies.

This is a study protocol with no results reported. The observational design limits ability to establish causality. Male-only sample restricts generalizability to females with autism. Single geographic location (Malaysia) may limit broader applicability.

Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterised by persistent deficits in social communication and the presence of restricted, repetitive behaviours or interests. Previous literature has identified a link between the gut and ASD; however, the underlying mechanisms remain unclear. Gut microbiota dysbiosis has been extensively reported in cohort studies of ASD, and specific microbial metabolites or by-products may serve as potential biomarkers for ASD. Additionally, children with ASD often exhibit food refusal, have a limited food repertoire and display a tendency to consume the same foods frequently; thus, these behaviours increase their risk of malnutrition (over-nutrition or under-nutrition) compared to typically developing (TD) healthy children.

This study primarily aims to identify oral and gut microbiota among children with ASD and TD healthy children. The secondary aim is to determine the associations between oral and gut microbiota with nutritional status among children with ASD. The findings will enhance understanding of the aetiology of ASD and inform early intervention strategies to mitigate disease severity and early identification of malnutrition in genetically at-risk children. This observational, age-matched, case-control study is conducted in Malaysia among 40 male children with ASD and age-matched with 40 TD healthy controls aged 4-10 years.

The dependent variables include the microbiota profile, identified through metagenomic sequencing analysis of saliva and faecal samples, and autism severity, assessed through validated questionnaires. Independent variables include nutritional status, determined through Subjective Global Nutrition Assessment (SGNA), anthropometry and dietary measurements, gastrointestinal symptoms, eating behaviour, behavioural profile, and sleep quality. Data collection is expected to be completed by June 2026. The study nature may limit causality establishment.

Analyses will use chi-square/ANOVA for group comparisons, SparCC for microbiota correlations, and mixed-effects logistic regression to model associations. This study advances understanding of ASD-related microbiota, guiding personalised nutrition and precision healthcare in Malaysia.