Gaougaou Ghizlane, Zahra Riham, Morel Sophia, Bélanger Véronique, Knoth Inga Sophia, Cousineau Dominique, D'Arc Baudouin Forgeot, Grzywacz Kelly, Rousseau Guy, Déziel Eric, Godbout Roger, Lippé Sarah, Millette Mathieu, Marcil Valérie
Department of Nutrition, Université de Montréal, Montreal, QC, H3 T 1 A8, Canada.
Centre de recherche Azrieli du CHU Sainte-Justine, 3175 Côte Sainte-Catherine, Montreal, QC, H3 T 1 C5, Canada.
J Neurodev Disord. 2025 May 24;17(1):30. doi: 10.1186/s11689-025-09617-5.
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.
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.
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.
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.
自闭症谱系障碍（ASD）是一组神经发育障碍，其特征为刻板行为以及社交沟通和社交互动方面的挑战。ASD与多种共病相关，包括焦虑、胃肠道（GI）症状和睡眠障碍。有证据支持肠道微生物群失调与ASD相关症状的严重程度之间存在关联。有人提出摄入益生菌可恢复微生物稳态，并减轻自闭症患者的神经行为、胃肠道和睡眠症状。
本研究旨在评估Bio-K +益生菌饮料在4至11岁自闭症儿童中的可接受性和安全性，以及所提议的研究方案测量其对行为和共病影响的可行性。这项为期30周的研究包括每天补充Bio-K +益生菌，持续14周。在整个研究过程中监测可接受性和安全性。通过将招募率和完成率与预先设定的阈值进行比较来评估可行性。评估补充剂对行为（自闭症治疗评估清单（ATEC）评分）、胃肠道症状和睡眠障碍的初步影响。
在招募的23名儿童（平均年龄6.7±2.2岁，70%为男性）中，65%有胃肠道问题，91%有睡眠障碍。所有参与者都接受了益生菌补充，且未报告与产品相关的不良事件。几乎所有研究结果的可行性率都超过了预先设定的阈值，包括招募率、依从性、脑电图、活动记录仪和问卷完成情况。初步数据表明，用ATEC总分评估的与自闭症相关的行为以及胃肠道症状和睡眠障碍有所改善。
本研究证明了益生菌饮料在自闭症儿童中的可接受性、安全性和方案可行性。为了进一步支持我们的数据，需要进行一项双盲安慰剂对照研究来确定其疗效。
