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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BMC
2025-05-01
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| 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. |
| format | Article |
| id | doaj-art-afa2996f96b04fd79858e17a638ce585 |
| institution | DOAJ |
| issn | 1866-1955 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | BMC |
| record_format | Article |
| series | Journal of Neurodevelopmental Disorders |
| 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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