Impact of probiotic supplements on behavioural and gastrointestinal symptoms in children with autism spectrum disorder: A randomised controlled trial.

IF 2 4区医学 Q2 PEDIATRICS BMJ Paediatrics Open Pub Date : 2025-03-04 DOI:10.1136/bmjpo-2024-003045

Himani Narula Khanna, Sushovan Roy, Aqsa Shaikh, Rajiv Chhabra, Azhar Uddin

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Abstract

Objective: To 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.

Design: Single-blinded, randomised, placebo-controlled study.

Setting: Five developmental paediatric outpatient clinics of 'Continua Kids'.

Patients: Children aged 2-9 years diagnosed with ASD along with their caregivers.

Interventions: Probiotic or placebo sachet reconstituted in 50 mL of lukewarm milk/water, taken two times per day for 3 months.

Main outcome measures: Change 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.

Results: A 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.

Conclusions: Probiotic 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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