Trial reportJournal of autism and developmental disorders2025
A Double-Blind Randomised Controlled Trial of Prebiotic Supplementation in Children with Autism: Effects on Parental Quality of Life, Child Behaviour, Gastrointestinal Symptoms, and the Microbiome.
Trial report in Journal of autism and developmental disorders, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
10 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Adverse event monitoring, assessment, and reporting in nutraceutical and phytoceutical trials for pediatric neuropsychiatric conditions: A systematic review.Journal of psychopharmacology (Oxford, England) · 2025Pooled it
- Effect of nutritional supplements on gut microbiome in individuals with neurodevelopmental disorders: a systematic review and narrative synthesis.BMC nutrition · 2025Pooled it
- Microbiota-based interventions for autism spectrum disorder: a systematic review of efficacy and clinical potential.Frontiers in microbiology · 2025Pooled it
- Effect of prebiotics on gastrointestinal symptoms and quality of life in children with intestinal failure: A pilot study.Journal of pediatric gastroenterology and nutrition · 2025Trial
- Review
- Short-Chain Fatty Acid-Dependent Neuroimmune Regulation in Autism Spectrum Disorder Pathogenesis.The European journal of neuroscience · 2026Review
- Effects of nutritional supplementation on social impairment and behavioral dysregulation in autism spectrum disorder: a network meta-analysis.BMC psychiatry · 2026Article
- The overlooked role of microbiota-gut-brain communication in child psychiatry: a call for integration in early intervention strategies.Communicative & integrative biology · 2025Article
- Gut microbiota and autism spectrum disorder: advances in dietary intervention strategies based on the microbiota-gut-brain axis mechanism.Frontiers in neuroscience · 2025Review
- Nutritional management and autism spectrum disorder: A systematic review.World journal of clinical pediatrics · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeModifying gut bacteria in children with autism may influence behaviour, with potential to improve family functioning. We conducted a randomised controlled trial to assess the effect of prebiotics on behaviour, gastrointestinal symptoms and downstream effects on parental quality of life.
methodChildren with autism (4-10yrs) were randomised to 2.4 g/d of prebiotic (GOS) or placebo for six weeks. Pre and post stools samples were collected, and validated questionnaires used to measure change in social and mealtime behaviours, GI symptoms and pQOL. Linear mixed models evaluated group differences for behavioural variables, and Mann Whitney U tests were used to compare change between-groups for GI symptoms, differential abundance of genera and alpha diversity of the microbiome.
resultsThirty-three parent-child dyads completed the trial. No group difference was seen for behavioural variables but both groups improved significantly from baseline. There was a medium effect size between groups for GI symptoms (d = 0.47) and pQOL (d = 0.44) driven by greater improvements in the prebiotic group. Bifidobacterium increased threefold following prebiotics (1.4-5.9%, p < 0.001) with no change in controls. Supplements were well tolerated, compliance with dose 94%.
conclusionPrebiotics modify levels of Bifidobacterium and prove well tolerated but in this instance, resulted in only marginal effects on GI symptoms and pQOL. A larger sample of children with more severe symptoms could help to determine the potential of prebiotics in autism.
trial registrationhttps://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12619000615189 .
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