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The Effect of a Multispecies Probiotics on Autism Symptoms in Children

Study acronym: PROBAUT
StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated January 8, 2026 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary endpoints: 2 to 1v4 Show 4 more changesShow less
    • Secondary endpoints: 4 to 5
    • Site contacts updated at 1 of 3 sites
    • Study description shortened, about 1 word
    • Study title shortened, about 5 words
  2. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Enrollment target: 108 to 110
    • Study sites: 1 to 3
    • Study completion date: Jul 2026 to Jul 30, 2026
    • Start date changed from estimate of Jun 2024 to Aug 7, 2024
  3. Secondary endpoints revised (4)
    • Eligibility criteria shortened, about 1 word
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06448767
Lead Sponsor Medical University of Warsaw
Collaborators: Winclove Probiotics B.V.
Conditions
(from sponsor)		 Autism Spectrum Disorder
Related terms Autism Spectrum Disorder
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov