Health TrialsbyHealthPanel

The Effect of a Multispecies Probiotics on Autism Symptoms in Children

ConditionAutism Spectrum Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-15
SponsorMedical University of Warsaw

About this trial

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, quality of life, gastrointestinal symptoms, sleep disturbances, parental stress levels and urinary p-cresol concentrations in children with Autism Spectrum Disorder aged 7 to 15 years.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

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

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.

Disqualifiers

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

Use of probiotics or synbiotics within the previous 2 months.

History of intolerance or allergy to probiotics, synbiotics or any other study product component.

Surgery with bowel resection or short bowel syndrome.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Multispecies probiotics

    Dietary supplement

    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.

  • Placebo

    Other intervention

    Placebo identical in taste, smell and color to the multispecies probiotics.

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Multispecies probiotics groupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
0-3 months

Secondary outcomes

1

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.

Time frame
0-3 months
2

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.

Time frame
0-3 months
3

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.

Time frame
0-3 months
4

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.

Time frame
0-3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of Warsaw

Lead sponsor

Winclove Probiotics B.V.

Collaborator

Source ClinicalTrials.gov
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