Autism Spectrum DisorderPROBAUTNCT06448767
The Effect of a Multispecies Probiotics on Autism Symptoms in Children
A study testing Multispecies probiotics in people with Autism Spectrum Disorder, run by Medical University of Warsaw at 3 sites in Poland.
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… Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Multispecies probiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 3 sitesPoland
- Study dates
- 7 Aug 2024to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland3 sites, 3 recruiting
- Recruiting
Department of Paediatrics, The Medical University of Warsaw
Warsaw, Warsaw, 02-091
Maja Kotowska, MD, +48223179536, maja.kotowska@uckwum.pl
Maja Kotowska, MD
- Recruiting
Department of Paediatrics, The Medical University of Warsaw
Warsaw, Warsaw, 02-091
Maja Kotowska, 223179535, maja.kotowska@uckwum.pl
- Recruiting
Department of Paediatrics, The Medical University of Warsaw
Warsaw, Warsaw, 02-091
Maja Kotowska, MD, +223179444, maja.kotowska@uckwum.pl
About this study
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.
Read the detailed description
This study is a randomized, double-blind, placebo-controlled clinical trial. One hundred and ten 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 primary outcome will be the assessment of core autism symptoms using the Autism Symptom Rating Scales (ASRS). The secondary outcomes will include: the quality of life measured by the Quality of Life in Autism Part A questionnaire (QoLA-A), 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Multispecies probiotics, Placebo
- Keywords
- Autism Spectrum Disorder, Probiotics
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multispecies probioticsDietary 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.
PlaceboOther
Placebo identical in taste, smell and color to the multispecies probiotics.
| Study group | Role | What they receive |
|---|---|---|
| Multispecies probiotics group | Experimental | 55 participants Receives: Dietary Supplement: Multispecies probiotics |
| Control group | Placebo comparator | 55 participants Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-3 months
Secondary outcomes (5)
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.
Measured: 0-3 months
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.
Measured: 0-3 months
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.
Measured: 0-3 months
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.
Measured: 0-3 months
P-cresol levels in urine samples
Assessment of the level of p-cresol in urine samples.
Measured: 0-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start7 Aug 2024
- Primary completionJul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Winclove Probiotics B.V.
- Responsible party
- Sponsor
- Investigators
- Maja Kotowska, MD, Principal investigator, Department of Paediatrics, The Medical University of Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448767
- Sponsor's protocol ID
- KB/151/2023
- Acronym
- PROBAUT
- Status last verified
- Jul 2025
- First submitted
- 3 Jun 2024
- Last updated
- 8 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41422017
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Multispecies Probiotics on Autism Symptoms in Children
- ClinicalTrials.gov ID
- NCT06448767
- Acronym / sponsor ID
- PROBAUT / KB/151/2023
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, Probiotics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- Winclove Probiotics B.V.
- Study start
- 7 Aug 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a randomized, double-blind, placebo-controlled clinical trial. One hundred and ten 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 primary outcome will be the assessment of core autism symptoms using the Autism Symptom Rating Scales (ASRS). The secondary outcomes will include: the quality of life measured by the Quality of Life in Autism Part A questionnaire (QoLA-A), 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multispecies probiotics group | Experimental | Dietary Supplement: Multispecies probiotics55 participants |
| Control group | Placebo comparator | Other: Placebo55 participants |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multispecies probioticsMultispecies 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. | Dietary supplement | Multispecies probiotics group |
| PlaceboPlacebo identical in taste, smell and color to the multispecies probiotics. | Other | Control group |
Primary outcome
The Autism Spectrum Rating Scales (ASRS)
Time frame: 0-3 months
Assessment of the severity of ASD symptoms. Scores are reported as percentiles, with higher values indicating greater symptom severity.
5 secondary outcomes
The Parenting Stress Index, 4th Edition (PSI-4) / SIPA (Stress Index for Parents of Adolescents)
Time frame: 0-3 months
Children Sleep Habit Questionnaire - Abbreviated (CSHQ-A)
Time frame: 0-3 months
The Quality of Life in Autism Part A (QoLA-A)
Time frame: 0-3 months
Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: 0-3 months
P-cresol levels in urine samples
Time frame: 0-3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Derived from this study: PubMed 41422017Kotowska-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maja Kotowska, MD principal investigator
Department of Paediatrics, The Medical University of Warsaw, Poland
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multispecies probiotics in people with Autism Spectrum Disorder, run by Medical University of Warsaw at 3 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maja Kotowska, MD (+48223179536, kotowska.maja@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Autism Spectrum Rating Scales (ASRS) (time frame: 0-3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06448767, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.