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

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 disor...

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Main Authors: 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
Format: Article
Language:English
Published: BMC 2025-05-01
Series:Journal of Neurodevelopmental Disorders
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Online Access:https://doi.org/10.1186/s11689-025-09617-5
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author 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
author_facet 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
author_sort Ghizlane Gaougaou
collection DOAJ
description 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.
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spelling doaj-art-afa2996f96b04fd79858e17a638ce5852025-08-20T03:08:24ZengBMCJournal of Neurodevelopmental Disorders1866-19552025-05-0117111710.1186/s11689-025-09617-5Acceptability and safety of a probiotic beverage supplementation (Bio-K +) and feasibility of the proposed protocol in children with a diagnosis of autism spectrum disorderGhizlane Gaougaou0Riham Zahra1Sophia Morel2Véronique Bélanger3Inga Sophia Knoth4Dominique Cousineau5Baudouin Forgeot D’Arc6Kelly Grzywacz7Guy Rousseau8Eric Déziel9Roger Godbout10Sarah Lippé11Mathieu Millette12Valérie Marcil13Department of Nutrition, Université de MontréalBio-K Plus International Inc., Kerry (Canada) Inc.Department of Nutrition, Université de MontréalDepartment of Nutrition, Université de MontréalDepartment of Psychology, Université de MontréalDepartment of Pediatrics, Université de MontréalDepartment of Psychiatry, Université de MontréalDivision of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, CHU Sainte-JustineResearch Center, Centre Intégré Universitaire du Nord-de-L’Île-de-MontréalCentre Armand-Frappier Santé Biotechnologie, Institut National de La Recherche Scientifique (INRS)Department of Psychiatry, Université de MontréalDepartment of Psychology, Université de MontréalBio-K Plus International Inc., Kerry (Canada) Inc.Department of Nutrition, Université de MontréalAbstract 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.https://doi.org/10.1186/s11689-025-09617-5Autism spectrum disordersProbioticsAcceptabilitySafetyFeasibilityChildren
spellingShingle 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
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
Journal of Neurodevelopmental Disorders
Autism spectrum disorders
Probiotics
Acceptability
Safety
Feasibility
Children
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Autism spectrum disorders
Probiotics
Acceptability
Safety
Feasibility
Children
url https://doi.org/10.1186/s11689-025-09617-5
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