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

Not Applicable

Recruiting

• Conditions: Autism Spectrum Disorder
• Interventions: Other: Placebo; Dietary Supplement: Multispecies probiotics

• Registration Number: NCT06448767
• Lead Sponsor: Medical University of Warsaw

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-06-03
• Study First Submitted QC: 2024-06-03
• Study First Posted: 2024-06-07
• Study Start: 2024-08-07
• Last Update Submitted: 2024-11-06
• Last Update Posted: 2024-11-11
• Primary Completion: 2026-07
• Study Completion: 2026-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1. 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).
2. Children either not taking any medication or receiving the same medication for the last 2 months.
3. 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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Placebo	54 participants
Multispecies probiotics group	Multispecies probiotics	54 participants

Primary Outcome Measures

Name	Time	Method
The Autism Spectrum Rating Scales (ASRS)	0-3 months	Assessment of the severity of ASD symptoms. Scores are reported as percentiles, with higher values indicating greater symptom severity.
The Quality of Life in Autism Part A (QoLA-A)	0-3 months	Assessment of the quality of life of parents of children with ASD. Scores range from 28 to 140 points, with higher values reflecting a better quality of life.

Secondary Outcome Measures

Name	Time	Method
The Parenting Stress Index, 4th Edition (PSI-4) / SIPA (Stress Index for Parents of Adolescents)	0-3 months	Assessment of the parenting stress intensity. The level of parental stress will be assessed using the PSI-4 questionnaire if the child is under 11 years old, or the SIPA if the child is 11 years or older. Scores range from 101 to 505 points for the PSI-4 and 90 to 450 points for the SIPA. Higher scores indicate higher level of stress.
Children Sleep Habit Questionnaire - Abbreviated (CSHQ-A)	0-3 months	Assessment of the sleep impairments. Scores range from 0 to 154 points, with higher values indicating a greater severity of sleep disturbances.
Gastrointestinal Symptom Rating Scale (GSRS)	0-3 months	Assessment of the severity of gastrointestinal symptoms. Scores range from 15 to 105 points, with higher values indicating greater severity of gastrointestinal symptoms.
P-cresol levels in urine samples	0-3 months	Assessment of the level of p-cresol in urine samples.

Trial Locations

Locations (1)

Department of Paediatrics, The Medical University of Warsaw; 🇵🇱 Warsaw, Poland