NCT07845253

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Oct 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 28, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

October 15, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2027

Last Updated

September 30, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 22, 2026

Last Update Submit

September 28, 2026

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

  • Changes in Social Responsiveness Scale-2 (SRS-2) score

    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)

Secondary Outcomes (5)

  • Change in Autism Diagnostic Observation Schedule, 2nd Ed (ADOS-2) Calibrated Severity Score (CSS) for Social Affect

    From baseline to end of study (6 months)

  • Change in total Autism Diagnostic Observation Schedule, 2nd Ed (ADOS-2) score

    From baseline to end of study (6 months)

  • Change in GI symptoms

    From baseline to end fo study (6 months)

  • Change in ABAS-2 score

    From baseline to end fo study (6 months)

  • Proportion of responders

    At 6 months

Other Outcomes (4)

  • Change in Family Quality of Life

    From baseline to end fo study (6 months)

  • Change in quality of sleep

    From baseline to end of study (6 months)

  • Impact of dietary habits

    At baseline and end of study (6 months)

  • +1 more other outcomes

Study Arms (2)

Probiotics

EXPERIMENTAL

Probiotic oil drops formulation. Administered once daily.

Dietary Supplement: Probiotics

Placebo

PLACEBO COMPARATOR

Placebo oil drops formulation. Administered once daily.

Dietary Supplement: Placebo

Interventions

ProbioticsDIETARY_SUPPLEMENT

Combination of L. reuteri strains.

Probiotics
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanatorio Maipú

Mendoza, Maipú, M5515DUF, Argentina

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Romina L Squartini, MD

    Sanatorio Maipú

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanna H Nystrom, PhD

CONTACT

+46761483866sny@biogaia.se

Anna Pauter, PhD

CONTACT

+46 76 328 04 77anp@biogaia.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2026

First Posted

September 28, 2026

Study Start (Estimated)

October 15, 2026

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2027

Last Updated

September 30, 2026

Record last verified: 2026-09

Locations

AR(1)