Evidence map›Paper›PMID 40413384›Full record

ArticleJournal of neurodevelopmental disorders2025

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.

Ghizlane Gaougaou, Riham Zahra, Sophia Morel, Véronique Bélanger, Inga Sophia Knoth, Dominique Cousineau, Baudouin Forgeot D'Arc, Kelly Grzywacz, Guy Rousseau, Eric Déziel and 4 more

Abstract read
In one paragraph

Article in Journal of neurodevelopmental disorders, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Ghizlane GaougaouDepartment of Nutrition, Université de Montréal, Montreal, QC, H3 T 1 A8, Canada.
Riham ZahraBio-K Plus International Inc., Kerry (Canada) Inc., 495 Armand-Frappier Boulevard, Laval, QC, H7 V 4B3, Canada.
Sophia MorelDepartment of Nutrition, Université de Montréal, Montreal, QC, H3 T 1 A8, Canada.
Véronique BélangerDepartment of Nutrition, Université de Montréal, Montreal, QC, H3 T 1 A8, Canada.
Inga Sophia KnothDepartment of Psychology, Université de Montréal, Montreal, QC, H3 T 1 A8, Canada.
Dominique CousineauDepartment of Pediatrics, Université de Montréal, Montreal, QC, H3 T 1 C5, Canada.
Baudouin Forgeot D'ArcDepartment of Psychiatry, Université de Montréal, Montréal, QC, H3 C 3 J7, Canada.
Kelly GrzywaczDivision of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, CHU Sainte-Justine, Montreal, QC, H3 T 1 C5, Canada.
Guy RousseauResearch Center, Centre Intégré Universitaire du Nord-de-L'Île-de-Montréal, Montreal, QC, H1E 1 A4, Canada.
Eric DézielCentre Armand-Frappier Santé Biotechnologie, Institut National de La Recherche Scientifique (INRS), Laval, QC, H7 V 1B7, Canada.
Roger GodboutDepartment of Psychiatry, Université de Montréal, Montréal, QC, H3 C 3 J7, Canada.
Sarah LippéDepartment of Psychology, Université de Montréal, Montreal, QC, H3 T 1 A8, Canada.
Mathieu MilletteBio-K Plus International Inc., Kerry (Canada) Inc., 495 Armand-Frappier Boulevard, Laval, QC, H7 V 4B3, Canada.
Valérie MarcilDepartment of Nutrition, Université de Montréal, Montreal, QC, H3 T 1 A8, Canada. valerie.marcil@umontreal.ca.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAutism 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.

methodsThis 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.

resultsOf 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.

conclusionThis 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.

Indexed as

Autism Spectrum DisorderBeveragesDietary SupplementsPatient Acceptance of Health CareProbioticsChildChild, PreschoolFeasibility StudiesFemaleGastrointestinal DiseasesHumansMaleSleep Wake DisordersAcceptabilityAutism spectrum disordersAutistic symptomsChildrenFeasibilityGastrointestinal symptomsProbioticsSafetySleep disorder

Identifiers

PMID40413384
PMCPMC12102953

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.