NCT06448767

The Effect of a Multispecies Probiotics on Autism Symptoms in Children

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 7 Years – 15 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-08-07
• Primary completion: 2026-07-01
• Completion: 2026-07-30
• First posted: 2024-06-07
• Last updated: 2026-01-08

Locations

3 sites across 1 country: Poland