The Effect of a Multispecies Probiotics on Autism Symptoms in Children

NCT06448767 | Recruiting

• 1 other identifier: KB/151/2023
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 3

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, 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.

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder; Probiotics

Outcome Measures

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.

  0-3 months

Secondary Outcomes (5)

• The Parenting Stress Index, 4th Edition (PSI-4) / SIPA (Stress Index for Parents of Adolescents)

  0-3 months

• Children Sleep Habit Questionnaire - Abbreviated (CSHQ-A)

  0-3 months

• The Quality of Life in Autism Part A (QoLA-A)

  0-3 months

• Gastrointestinal Symptom Rating Scale (GSRS)

  0-3 months

• P-cresol levels in urine samples

  0-3 months

Study Arms (2)

Multispecies probiotics group

EXPERIMENTAL

55 participants

Dietary Supplement: Multispecies probiotics

Control group

PLACEBO COMPARATOR

55 participants

Other: Placebo

Interventions

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.

Multispecies probiotics group

Placebo OTHER

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

Control group

Eligibility Criteria

• Age: 7 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Children with severe immunodeficiency.

Sponsors & Collaborators

• Medical University of Warsaw: lead
• Winclove Probiotics B.V.: collaborator

Study Sites (3)

Department of Paediatrics, The Medical University of Warsaw

Warsaw, Warsaw, 02-091, Poland

RECRUITING

Department of Paediatrics, The Medical University of Warsaw

Warsaw, Warsaw, 02-091, Poland

RECRUITING

Department of Paediatrics, The Medical University of Warsaw

Warsaw, Warsaw, 02-091, Poland

RECRUITING

Related Publications (1)

• Kotowska-Babol M, Konowalek L, Szajewska H, Lukasik J. Effect of multispecies probiotics on autism symptoms: protocol for a randomized controlled trial (PROBAUT). Trials. 2025 Dec 20;26(1):573. doi: 10.1186/s13063-025-09373-w.

  PMID: 41422017 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Maja Kotowska, MD

  Department of Paediatrics, The Medical University of Warsaw, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maja Kotowska, MD

CONTACT

+48223179536; kotowska.maja@gmail.com

Jan Łukasik, MD, PhD

CONTACT

+48223179536; jan.lukasik@wum.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 7, 2024
• Study Start: August 7, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: January 8, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PL (3)