Acceptability and safety of a probiotic beverage supplementation (Bio-K +) and feasibility of the proposed protocol in children with a diagnosis of autism spectrum disorder.

IF 4 2区医学 Q1 CLINICAL NEUROLOGY

Journal of Neurodevelopmental Disorders Pub Date : 2025-05-24 DOI:10.1186/s11689-025-09617-5

Ghizlane Gaougaou, Riham Zahra, Sophia Morel, Véronique Bélanger, Inga Sophia Knoth, Dominique Cousineau, Baudouin Forgeot D'Arc, Kelly Grzywacz, Guy Rousseau, Eric Déziel, Roger Godbout, Sarah Lippé, Mathieu Millette, Valérie Marcil

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引用次数: 0

Abstract

Background: Autism spectrum disorder (ASD) is a group of neurodevelopmental disorders defined by stereotyped behavior and challenges in social communication and social interaction. ASD is associated with various comorbidities, including anxiety, gastrointestinal (GI) symptoms and sleep disorders. Evidence supports an association between intestinal dysbiosis and the severity of ASD-related symptoms. Probiotic intake was suggested to restore microbial homeostasis and decrease neurobehavioral, GI and sleep symptoms in individuals diagnosed with autism.

Methods: This study aims to evaluate the acceptability and safety of a Bio-K + probiotics beverage in autistic children aged 4 to 11 years and the feasibility of the proposed research protocol to measure its impact on behaviors and comorbidities. The 30-week study consisted of daily supplementation with Bio-K + probiotics for 14 weeks. Acceptability and safety were monitored throughout the study. Feasibility was assessed by comparing recruitment and completion rates to pre-established thresholds. Preliminary impact of supplementation on behaviors (Autism Treatment Evaluation Checklist (ATEC) score), GI symptoms and sleep disorders was evaluated.

Results: Of the 23 children recruited (mean age 6.7 ± 2.2 years, 70% males), 65% had GI problems and 91% had sleep disorders. Probiotic supplementation was accepted by all participants and no product-related adverse event was reported. Feasibility rates exceeded pre-established thresholds for almost all study outcomes including recruitment rate, compliance, electroencephalography, actigraphy and completion of questionnaires. Preliminary data suggest an improvement in behaviors associated with autism assessed with the total ATEC score, and in GI symptoms and sleep disorders.

Conclusion: This study demonstrates probiotic beverage acceptability and safety and protocol feasibility in autistic children. To further support our data, a double-blinded placebo-controlled study is needed to determine its efficacy.

查看原文本刊更多论文

益生菌饮料补充剂（Bio-K +）在自闭症谱系障碍儿童中的可接受性和安全性以及拟议方案的可行性。

背景：自闭症谱系障碍（Autism spectrum disorder， ASD）是一组以刻板行为和社会沟通和社会互动方面的挑战为特征的神经发育障碍。ASD与多种合并症有关，包括焦虑、胃肠道（GI）症状和睡眠障碍。证据支持肠道生态失调与asd相关症状的严重程度之间存在关联。建议益生菌摄入恢复微生物稳态，减少自闭症患者的神经行为、胃肠道和睡眠症状。方法：本研究旨在评估Bio-K +益生菌饮料在4 - 11岁自闭症儿童中的可接受性和安全性，以及所提出的研究方案的可行性，以衡量其对行为和合并症的影响。这项为期30周的研究包括在14周内每天补充Bio-K +益生菌。在整个研究过程中对可接受性和安全性进行了监测。通过将招聘和完成率与预先设定的阈值进行比较来评估可行性。评估了补充剂对行为（自闭症治疗评估表（ATEC）评分）、胃肠道症状和睡眠障碍的初步影响。结果：在招募的23名儿童中（平均年龄6.7±2.2岁，70%为男性），65%有胃肠道问题，91%有睡眠障碍。益生菌补充剂被所有参与者接受，没有产品相关的不良事件报告。几乎所有研究结果的可行性都超过了预先设定的阈值，包括招募率、依从性、脑电图、活动描记和问卷完成情况。初步数据显示，用ATEC总分评估的与自闭症相关的行为、胃肠道症状和睡眠障碍都有所改善。结论：本研究证明了益生菌饮料在自闭症儿童中的可接受性、安全性和方案的可行性。为了进一步支持我们的数据，需要一项双盲安慰剂对照研究来确定其疗效。

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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来源期刊

Journal of Neurodevelopmental Disorders 医学-临床神经学

CiteScore

7.60

自引率

4.10%

发文量

审稿时长

>12 weeks

期刊介绍： Journal of Neurodevelopmental Disorders is an open access journal that integrates current, cutting-edge research across a number of disciplines, including neurobiology, genetics, cognitive neuroscience, psychiatry and psychology. The journal’s primary focus is on the pathogenesis of neurodevelopmental disorders including autism, fragile X syndrome, tuberous sclerosis, Turner Syndrome, 22q Deletion Syndrome, Prader-Willi and Angelman Syndrome, Williams syndrome, lysosomal storage diseases, dyslexia, specific language impairment and fetal alcohol syndrome. With the discovery of specific genes underlying neurodevelopmental syndromes, the emergence of powerful tools for studying neural circuitry, and the development of new approaches for exploring molecular mechanisms, interdisciplinary research on the pathogenesis of neurodevelopmental disorders is now increasingly common. Journal of Neurodevelopmental Disorders provides a unique venue for researchers interested in comparing and contrasting mechanisms and characteristics related to the pathogenesis of the full range of neurodevelopmental disorders, sharpening our understanding of the etiology and relevant phenotypes of each condition.