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Recruiting NCT06448767

The Effect of a Multispecies Probiotics on Autism Symptoms in Children

No phase Interventional Autism Spectrum Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Multispecies probiotics, Placebo.
Who it may be relevant to
Registry conditions: Autism Spectrum Disorder. Basic parameters: 7 years — 15 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

In this trial, the investigators aim to evaluate the impact of a multispecies probiotic consisting of Bacillus subtilis W201, Bifidobacterium infantis W17, Bifidobacterium lactis W51, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus rhamnosus W140, Lactococcus lactis W19, Propionibacterium freudenreichii W200, on the severity of autism symptoms, quality of life, gastrointestinal symptoms, sleep disturbances, parental stress levels and urinary p-cresol concentrations in children with Autism Spectrum Disorder aged 7 to 15 years.

Detailed description

This study is a randomized, double-blind, placebo-controlled clinical trial. One hundred and ten children aged 7 to 15 years diagnosed with Autism Spectrum Didorder will be randomly assigned in a 1:1 ratio to receive either a multispecies probiotics or a placebo for 12 weeks. The probiotic mixture contains 5 x 10\^9 colony forming units per dose consisting of Bacillus subtilis W201, Bifidobacterium infantis W17, Bifidobacterium lactis W51, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus rhamnosus W140, Lactococcus lactis W19, Propionibacterium freudenreichii W200.

The primary outcome will be the assessment of core autism symptoms using the Autism Symptom Rating Scales (ASRS). The secondary outcomes will include: the quality of life measured by the Quality of Life in Autism Part A questionnaire (QoLA-A), evaluations of sleep impairments using Children Sleep Habit Questionnaire - Abbreviated (CSHQ-A), parental stress levels using Parenting Stress Index-III (PSI-III), gastrointestinal symptoms using Gastrointestinal Symptom Rating Scale (GSRS), and urinary p-cresol levels. These outcomes will be assessed twice: at baseline and after 12 weeks of intervention.

Interventions

  • Dietary supplement Multispecies probiotics
    Multispecies probiotics consisting of Bacillus subtilis W201, Bifidobacterium infantis W17, Bifidobacterium lactis W51, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus rhamnosus W140, Lactococcus lactis W19, Propionibacterium freudenreichii W200 at a dose of 5x10\^9 Colony Forming Units (CFU), once daily, orally.
  • Other Placebo
    Placebo identical in taste, smell and color to the multispecies probiotics.

Primary outcome measures

  • The Autism Spectrum Rating Scales (ASRS) [Time frame: 0-3 months]
Secondary outcome measures (5)
  • The Parenting Stress Index, 4th Edition (PSI-4) / SIPA (Stress Index for Parents of Adolescents) [Time frame: 0-3 months]
  • Children Sleep Habit Questionnaire - Abbreviated (CSHQ-A) [Time frame: 0-3 months]
  • The Quality of Life in Autism Part A (QoLA-A) [Time frame: 0-3 months]
  • Gastrointestinal Symptom Rating Scale (GSRS) [Time frame: 0-3 months]
  • P-cresol levels in urine samples [Time frame: 0-3 months]

Eligibility criteria

Inclusion criteria

  • Diagnosis of ASD according to the Diagnostic and Statistical Manual of Mental Disorders, the fifth edition (DSM-5) or International Classification of Diseases, Tenth Revision (ICD-10).
  • Children either not taking any medication or receiving the same medication for the last 2 months.
  • Patients, or their parents/caregivers, are willing to provide written informed consent, proceed with nutritional supplements throughout the 3-month trial, refrain from starting any kind of special diet for the duration of the study, and complete the questionnaires at two time points during the study.

Exclusion criteria

  • Use of antibiotics in the previous 2 months before enrolling (excluding topical antibiotics).
  • Use of probiotics or synbiotics within the previous 2 months.
  • History of intolerance or allergy to probiotics, synbiotics or any other study product component.
  • Surgery with bowel resection or short bowel syndrome.
  • Children with severe immunodeficiency.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Poland · 3 centers
  • Department of Paediatrics, The Medical University of Warsaw — Warsaw
  • Department of Paediatrics, The Medical University of Warsaw — Warsaw
  • Department of Paediatrics, The Medical University of Warsaw — Warsaw

Publications

  • Kotowska-Babol M, Konowalek L, Szajewska H, Lukasik J. Effect of multispecies probiotics on autism symptoms: protocol for a randomized controlled trial (PROBAUT). Trials. 2025 Dec 20;26(1):573. doi: 10.1186/s13063-025-09373-w. PMID 41422017

Identifiers

NCT: NCT06448767 · KB/151/2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗