The Effect of a Multispecies Probiotics on Autism Symptoms and the Quality of Life in Children

Last updated: November 6, 2024
Sponsor: Medical University of Warsaw
Overall Status: Active - Recruiting

Phase

N/A

Condition

Autism

Asperger's Disorder

Autism Spectrum Disorder (Asd)

Treatment

Multispecies probiotics

Placebo

Clinical Study ID

NCT06448767
KB/151/2023
  • Ages 7-15
  • All Genders

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 and the quality of life in children with Autism Spectrum Disorder aged 7 to 15.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosis of ASD according to the Diagnostic and Statistical Manual of MentalDisorders, the fifth edition (DSM-5) or International Classification of Diseases,Tenth Revision (ICD-10).

  2. Children either not taking any medication or receiving the same medication for thelast 2 months.

  3. Patients, or their parents/caregivers, are willing to provide written informedconsent, proceed with nutritional supplements throughout the 3-month trial, refrainfrom starting any kind of special diet for the duration of the study, and completethe questionnaires at two time points during the study.

Exclusion

Exclusion Criteria:

  1. Use of antibiotics in the previous 2 months before enrolling (excluding topicalantibiotics).

  2. Use of probiotics or synbiotics within the previous 2 months.

  3. History of intolerance or allergy to probiotics, synbiotics or any other studyproduct component.

  4. Surgery with bowel resection or short bowel syndrome.

  5. Children with severe immunodeficiency.

Study Design

Total Participants: 110
Treatment Group(s): 2
Primary Treatment: Multispecies probiotics
Phase:
Study Start date:
August 07, 2024
Estimated Completion Date:
July 30, 2026

Study Description

This study is a randomized, double-blind, placebo-controlled clinical trial. One hundred and eight 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 two co-primary outcomes will be the assessment of core autism symptoms using the Autism Symptom Rating Scales (ASRS) and quality of life measured by the Quality of Life in Autism Part A questionnaire (QoLA-A). The secondary outcomes will include 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.

Connect with a study center

  • Department of Paediatrics, The Medical University of Warsaw

    Warsaw, 02-091
    Poland

    Active - Recruiting

  • Department of Paediatrics, The Medical University of Warsaw, Poland

    Warsaw, 02-091
    Poland

    Site Not Available

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