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

Autism Spectrum Disorder Clinical Trial

— PROBAUT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06448767
• Other study ID #: KB/151/2023
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: July 2026

Study information

• Verified date: May 2024
• Source: Medical University of Warsaw
• Contact: Maja Kotowska, MD
• Phone: +48223179536
• Email: kotowska.maja[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 108
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

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.

Locations

Country	Name	City	State
Poland	Department of Paediatrics, The Medical University of Warsaw, Poland	Warsaw

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Warsaw	Winclove Probiotics B.V.

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Autism Spectrum Rating Scales (ASRS)	Assessment of the severity of ASD symptoms. Scores are reported as percentiles, with higher values indicating greater symptom severity.	0-3 months
Primary	The Quality of Life in Autism Part A (QoLA-A)	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.	0-3 months
Secondary	The Parenting Stress Index, 4th Edition (PSI-4) / SIPA (Stress Index for Parents of Adolescents)	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.	0-3 months
Secondary	Children Sleep Habit Questionnaire - Abbreviated (CSHQ-A)	Assessment of the sleep impairments. Scores range from 0 to 154 points, with higher values indicating a greater severity of sleep disturbances.	0-3 months
Secondary	Gastrointestinal Symptom Rating Scale (GSRS)	Assessment of the severity of gastrointestinal symptoms. Scores range from 15 to 105 points, with higher values indicating greater severity of gastrointestinal symptoms.	0-3 months
Secondary	P-cresol levels in urine samples	Assessment of the level of p-cresol in urine samples.	0-3 months