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Effect of Limosilactobacillus Reuteri on Social Deficits in Children With Autistic Spectrum Disorder

28. september 2026 opdateret af: BioGaia AB

Effect of Limosilactobacillus Reuteri on Social Deficits in Children With Autistic Spectrum Disorder: a Double-blind, Randomized, Placebo-controlled, Parallel-group Clinical Study

This is a double-blind, randomized, placebo-controlled, parallel-group study in children with Autism Spectrum Disorder (ASD) to evaluate the effect of a probiotic product on the ASD symptoms.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

200

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Sanna H Nystrom, PhD
  • Telefonnummer: +46761483866
  • E-mail: sny@biogaia.se

Undersøgelse Kontakt Backup

  • Navn: Anna Pauter, PhD
  • Telefonnummer: +46 76 328 04 77
  • E-mail: anp@biogaia.se

Studiesteder

  • Argentina
    • Maipú
      • Mendoza, Maipú, Argentina, M5515DUF
        • Sanatorio Maipú
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Romina L Squartini, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

4 år til 12 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Boys or girls aged between 4 to 12 years at screening.
  • ASD diagnosis confirmed by a qualified clinician according to DMS-5 criteria, M-CHAT used as a screening tool.
  • Parents/caregivers/legal guardians are ≥18 years.
  • Readiness and the opportunity for parents/caregivers/legal guardians to fill out a study diary, questionnaires, and report regularly during the intervention period.
  • Parents/caregivers/legal guardians with ability to understand and comply with the requirements of the study, as judged by the Investigator.
  • Parents/caregivers/legal guardians willing and able to give informed consent for their and their child's participation in the study.

Exclusion Criteria:

  • Neurological syndromes that could explain autism disorders.
  • Organic gastrointestinal disorders (e.g. IBD, peptic ulcers and cancer). Celiac disease is accepted
  • Any other severe clinically relevant disease or disorder which may affect the participation in the study, based on the investigator's judgement.
  • Allergy or intolerance to one of the excipients of the probiotic product.
  • Children with reported exposure to probiotic supplements in the 15 days prior to Screening Visit (V1).
  • Children with reported exposure to oral and/or systemic antibiotics in the 7 days prior to Screening Visit (V1).
  • Children with reported exposure to proton pump inhibitors in the 7 days prior to Screening Visit (V1).
  • Participation in other interventional clinical study.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Probiotics

Probiotic oil drops formulation. Administered once daily.
Kosttilskud: Probiotics

Combination of L. reuteri strains.
Placebo komparator: Placebo

Placebo oil drops formulation. Administered once daily.
Kosttilskud: Placebo

Placebo identical to the active product, except the addition of probiotics.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in Social Responsiveness Scale-2 (SRS-2) score
Tidsramme: From baseline to end of study (6 months)

Changes in the SRS-2 score in the L. reuteri group compared to the placebo group. The SRS-2 is a 65-item questionnaire, with higher scores indicating greater social impairment and severity of autism-related traits.
From baseline to end of study (6 months)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Autism Diagnostic Observation Schedule, 2nd Ed (ADOS-2) Calibrated Severity Score (CSS) for Social Affect
Tidsramme: From baseline to end of study (6 months)

Change in ADOS-2 CSS for Social Affect in the L. reuteri group compared to the placebo group.

ADOS-2 is a semi-structured, standardized assessment that observes social interaction, communication, play, and restricted or repetitive behaviors across five modules tailored to age and language level. Higher scores indicate a higher level of autism-related behaviors.
From baseline to end of study (6 months)
Change in total Autism Diagnostic Observation Schedule, 2nd Ed (ADOS-2) score
Tidsramme: From baseline to end of study (6 months)

Change in total ADOS-2 score in the L. reuteri group compared to the placebo group.

ADOS-2 is a semi-structured, standardized assessment that observes social interaction, communication, play, and restricted or repetitive behaviors across five modules tailored to age and language level. Higher scores indicate a higher level of autism-related behaviors.
From baseline to end of study (6 months)
Change in GI symptoms
Tidsramme: From baseline to end fo study (6 months)

Change in GI symptoms, assessed by the 6 item Gastrointestinal Severity Index (6-GSI) in the L. reuteri group compared to the placebo group.

6-GSI is a six item questionnaire with total score 0-12 with higher scores indicating worse outcome.
From baseline to end fo study (6 months)
Change in ABAS-2 score
Tidsramme: From baseline to end fo study (6 months)

Change in adaptive behaviour, assessed by the Adaptive Behavior Assessment System, Second Edition (ABAS-2) in the L. reuteri group compared to the placebo group.

ABAS-2 is a 4-point rating scale with the scoring system divided into skill area scores (range 1 to 19), domain scores (range 40 to 160) and general adaptive composite (40 to 150). A higher score indicates a better outcome.
From baseline to end fo study (6 months)
Proportion of responders
Tidsramme: At 6 months

Proportion of responders at 6 months, evaluating all assessments and questionnaires, in the L. reuteri group compared to the placebo group.
At 6 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Family Quality of Life
Tidsramme: From baseline to end fo study (6 months)

Change in family Quality of Life (QoL), assessed by the Pediatric Quality of Life Inventory™ Family Impact Module (PedsQL™ Family Impact Module), in the L. reuteri group compared to the placebo group.

The range of the total score is 0-100 with a higher score indicating a better outcome.
From baseline to end fo study (6 months)
Change in quality of sleep
Tidsramme: From baseline to end of study (6 months)

Change in sleep quality, assessed by the Children's Sleep Habits Questionnaire, in the L. reuteri group compared to placebo.

The CSHQ is scored on 33 of 52 items, using a 1-3 scale, with total score range 33-99. A higher score indicates worse outcome and the cut-off of a total score of 41 or higher indicating potential sleep problems.
From baseline to end of study (6 months)
Impact of dietary habits
Tidsramme: At baseline and end of study (6 months)

Impact of dietary habits, assessed by a Food Frequency Questionnaire (FFQ), on the gut microbiota profile and effect of the L. reuteri intervention.
At baseline and end of study (6 months)
Changes in gut microbiota structure and composition
Tidsramme: Baseline, 3 and 6 months

Changes in the gut microbiota structure and composition and the effect of the L. reuteri intervention, assessed by metagenomic analysis of fecal samples
Baseline, 3 and 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

BioGaia AB

Efterforskere

  • Ledende efterforsker: Romina L Squartini, MD, Sanatorio Maipú

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. oktober 2026

Primær færdiggørelse (Anslået)

31. oktober 2027

Studieafslutning (Anslået)

31. oktober 2027

Datoer for studieregistrering

Først indsendt

22. september 2026

Først indsendt, der opfyldte QC-kriterier

22. september 2026

Først opslået (Faktiske)

28. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CSUB0223

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