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

IF 2.3 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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益生菌补充剂对自闭症谱系障碍儿童行为和胃肠道症状的影响：一项随机对照试验

目的：探讨补充益生菌是否能改善2-9岁自闭症谱系障碍（ASD）儿童的行为和胃肠道（GI）症状，并进一步探讨这些症状之间的相关性。设计：单盲、随机、安慰剂对照研究。设置：“Continua Kids”的五个发育性儿科门诊。患者：2-9岁被诊断为ASD的儿童及其照顾者。干预措施：益生菌或安慰剂包在50毫升温牛奶/水中重组，每天服用两次，持续3个月。主要结果测量：接受干预3个月后行为（通过社会反应量表-2 （SRS-2）和异常行为清单-2 （ABC-2）工具测量）和GI（通过GI严重程度指数（GSI）评分测量）症状的改变。结果：共有180名ASD患儿入组，其中益生菌组90名，安慰剂组90名。所有的孩子都完成了这项研究。通过SRS-2工具测量，益生菌组的行为症状严重程度显著降低(47.77% vs 23.33%；P =0.000)。经益生菌治疗的儿童在干预后表现出严重症状的显著减少，包括社交退缩/嗜睡（40%）、刻板行为（37.77%）、多动（34.44%）和不当言语（32.22%）（p=0.000）。与安慰剂组相比，他们在便秘（p=0.003）和腹泻（p=0.043）方面也有明显改善。两组均表现出行为和胃肠道症状之间具有统计学意义的相关性。结论：补充益生菌可改善ASD患儿的行为和胃肠道症状，无不良反应。两种症状均显著相关。然而，这些结果需要在更大的样本量中进行验证。试验注册号：CTRI/2021/11/038213。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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