Trial reportBMJ paediatrics open2025
Impact of probiotic supplements on behavioural and gastrointestinal symptoms in children with autism spectrum disorder: A randomised controlled trial.
Trial report in BMJ paediatrics open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.
What it found
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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, 1 synthesis or guideline pooled it.
- Effects of Probiotic Supplementation on Core Symptoms of Autism Spectrum Disorder in Children.Nutrients · 2026Pooled it
- Anti-Inflammatory Diet and Probiotic Supplementation as Strategies to Modulate Immune Dysregulation in Autism Spectrum Disorder.Nutrients · 2025Trial
- Microbiota-dependent enterocyte oxytocin signaling in autism: mechanisms and translational implications.Molecular psychiatry · 2026Article
- Article
- Medical treatment of autism spectrum disorder in children: Current evidence, controversies, and clinical challenges.World journal of clinical pediatrics · 2026Article
- The Gut Microbiota-Tryptophan-Brain Axis in Autism Spectrum Disorder: A New Frontier for Probiotic Intervention.Microorganisms · 2026Review
- The therapeutic potential ofFrontiers in microbiology · 2026Review
- The gut microbiome as a modifiable contributor to autism spectrum disorder: a precision gut-immune-brain perspective.Frontiers in child and adolescent psychiatry · 2026Article
- The Microbiota-Gut-Brain Axis in Autism: Associations, Causal Inference, and Interventions-A Narrative Review.Pathogens (Basel, Switzerland) · 2025Review
- Probiotics as a Complementary Medicine in Neurologic Disorders.Health science reports · 2025Article
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
objectiveTo investigate whether probiotic supplementation can improve behavioural and gastrointestinal (GI) symptoms in children with autism spectrum disorder (ASD) aged 2-9 years and further explore the correlation between these symptoms.
designSingle-blinded, randomised, placebo-controlled study.
settingFive developmental paediatric outpatient clinics of 'Continua Kids'. PATIENTS: Children aged 2-9 years diagnosed with ASD along with their caregivers.
interventionsProbiotic or placebo sachet reconstituted in 50 mL of lukewarm milk/water, taken two times per day for 3 months.
main outcome measuresChange in behavioural (measured by Social Responsiveness Scale-2 (SRS-2) and Aberrant Behaviour Checklist-2 (ABC-2) tools) and GI (measured by GI Severity Index (GSI) score) symptoms after receiving intervention for 3 months.
resultsA total of 180 children with ASD were enrolled in the study (probiotic group: 90 and placebo group: 90). All children completed the study. The probiotic group showed a significant reduction in behavioural symptom severity as measured by the SRS-2 tool (47.77% vs 23.33%; p=0.000) compared with the placebo. Probiotic-treated children demonstrated significant reductions in severe symptoms, including social withdrawal/lethargy (40%), stereotypic behaviour (37.77%), hyperactivity (34.44%) and inappropriate speech (32.22%) post-intervention (p=0.000). They also had marked improvements in constipation (p=0.003) and diarrhoea (p=0.043) compared with the placebo group. Both groups exhibited a statistically significant correlation between behavioural and GI symptoms.
conclusionsProbiotic supplementation improved behavioural and GI symptoms in children with ASD with no adverse effects. Both symptoms were significantly correlated. However, these results need to be validated in a larger sample size. TRIAL REGISTRATION NUMBER: CTRI/2021/11/038213.
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