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Tests a probiotic for social difficulties in children with autism

Compares a probiotic with a placebo in children aged 4 to 12 with autism.

Key facts

Who runs it
BioGaia AB
Where
Mendoza, ArgentinaSee the site
Trial code
Registry title
Effect of Limosilactobacillus Reuteri on Social Deficits in Children With Autistic Spectrum Disorder
Status
Not yet recruiting
People taking part
200 people, planned
Started
15 Oct 2026
Expected to end
31 Oct 2027
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Probiotics
  • Placebo
Record updated
30 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children aged 4 to 12 years with a confirmed diagnosis of autism spectrum disorder. It tests a probiotic against a placebo.

Age
4 to 12 years
Sex
Boys and girls
Disease stage
Autism spectrum disorder confirmed by a qualified clinician using DMS-5 criteria; M-CHAT used as a screening tool.
Earlier treatment
No probiotic supplements in the 15 days before screening. No oral or systemic antibiotics and no proton pump inhibitors in the 7 days before screening.

Main reasons for not taking part

  • Neurological syndromes that could explain the autism
  • Organic gastrointestinal disorders such as IBD, peptic ulcers and cancer (celiac disease is accepted)
  • Allergy or intolerance to an ingredient of the probiotic product
  • Any other severe disease that may affect taking part, in the investigator's judgement
  • Taking part in another interventional clinical study

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)
  • 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
  • Participation in other interventional clinical study

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 4 and 12 years old?

Where in Argentina

  • Sanatorio MaipúMendoza, ArgentinaContact: Romina L Squartini, MDNo longer taking part

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • ProbioticsTreatment being tested

    Probiotic oil drops formulation. Administered once daily.

  • PlaceboPlacebo, for comparison

    Placebo oil drops formulation. Administered once daily.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Effect of Limosilactobacillus Reuteri on Social Deficits in Children With Autistic Spectrum Disorder: a Double-blind, Randomized, Placebo-controlled, Parallel-group Clinical Study
Plain-language title
Tests a probiotic for social difficulties in children with autismGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07845253, who can take part
Record updated
30 September 2026