Effect of multispecies probiotics on autism symptoms: protocol for a randomized controlled trial (PROBAUT).

ABSTRACT:

Introduction

Autism spectrum disorder (ASD) affects millions of children worldwide, negatively impacting the daily functioning and quality of life of patients and their families. New therapeutic approaches for ASD are being investigated. Probiotics have shown promise in modulating gut microbiota and ameliorating ASD symptoms. We aim to evaluate the impact of a 12-week multispecies probiotic supplementation on the severity of core autism symptoms in children with ASD.

Methods and analysis

This study is a randomized, double-blind, placebo-controlled clinical trial. One hundred and 10 children aged 7 to 15 years diagnosed with ASD will be randomly assigned in a 1:1 ratio to receive either a probiotic mixture or a placebo for 12 weeks. The probiotic mixture contains 5 × 10⁹

SUBMITTER: Kotowska-Babol M 

PROVIDER: S-EPMC12720436 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature