Could probiotics be a new way to help kids with autism?
NCT ID NCT06448767
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing whether a daily probiotic supplement can reduce autism symptoms, improve quality of life, and ease stomach problems in children with Autism Spectrum Disorder. About 110 children aged 7 to 15 will take the probiotic or a placebo for 3 months. Researchers will measure changes in behavior, sleep, and parent stress levels.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 110 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Jul 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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7 to 15 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of Paediatrics, The Medical University of Warsaw
RECRUITINGWarsaw, Warsaw, 02-091, Poland
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Department of Paediatrics, The Medical University of Warsaw
RECRUITINGWarsaw, Warsaw, 02-091, Poland
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Department of Paediatrics, The Medical University of Warsaw
RECRUITINGWarsaw, Warsaw, 02-091, Poland
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