Clinical trial NCT06448767: The Effect of a Multispecies Probiotics on Autism Symptoms and the Quality of Life in Children
Official title: The Effect of a Multispecies Probiotics on Autism Symptoms and the Quality of Life in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism Spectrum Disorder
Probiotics
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
Collaborators: name: Winclove Probiotics B.V.
First posted: 2024-06-07
Enrollment: 110
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Autism Spectrum Rating Scales (ASRS)
timeFrame: 0-3 months
measure: The Quality of Life in Autism Part A (QoLA-A)
timeFrame: 0-3 months
Secondary outcomes:
measure: The Parenting Stress Index, 4th Edition (PSI-4) / SIPA (Stress Index for Parents of Adolescents)
timeFrame: 0-3 months
measure: Children Sleep Habit Questionnaire - Abbreviated (CSHQ-A)
timeFrame: 0-3 months
measure: Gastrointestinal Symptom Rating Scale (GSRS)
timeFrame: 0-3 months
measure: P-cresol levels in urine samples
timeFrame: 0-3 months
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Paediatrics, The Medical University of Warsaw
city: Warsaw
country: Poland
facility: Department of Paediatrics, The Medical University of Warsaw
city: Warsaw
country: Poland
facility: Department of Paediatrics, The Medical University of Warsaw
Study officials:
affiliation: Department of Paediatrics, The Medical University of Warsaw, Poland
name: Maja Kotowska, MD
role: PRINCIPAL_INVESTIGATOR
References: