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The Effect of a Multispecies Probiotics on Autism Symptoms in Children

NCT06448767 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-01-08

No results posted yet for this study

Summary

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.

Conditions

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.

Sponsors & Collaborators

  • Winclove Probiotics B.V.

    collaborator INDUSTRY

  • Medical University of Warsaw

    lead OTHER

Principal Investigators

  • Maja Kotowska, MD · Department of Paediatrics, The Medical University of Warsaw, Poland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-07
Primary Completion
2026-07-31
Completion
2026-07-30

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06448767 on ClinicalTrials.gov