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The Intervention of Lactobacillus Plantarum Probiotics in Adult Autistic Spectrum Disorders

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
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Record History

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  1. Notable Primary endpoint(s) modified
    • Final enrollment: 15 participants (planned 12)
    • Secondary endpoints: 4 to 7
    • Site details revised
    v3
  2. Notable Primary completion date: Jun 30, 2026 to Dec 31, 2026
    • Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Study completion date: Aug 31, 2026 to Aug 31, 2027
    v2
  3. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Phase I: Post-hoc Analysis and Longitudinal Follow-up Due to the inherent difficulty in recruiting the target number of individuals with Autism Spectrum Disorder (ASD) and the logistical challenges related to securing consensus from workshops, families, and teachers, the initial study phase has been modified. The mixed-methods phase will now focus on leveraging the rich qualitative data already collected. We will seek ethical approval and consent from the fifteen preliminary study participants, their families, and teachers to conduct analysis of the existing interview content. Furthermore, these fifteen participants will be invited for a four-month follow-up assessment following the completion of the original 8-week intervention (post-test) to evaluate the persistence of observed changes after probiotic cessation. At this follow-up, teachers will re-evaluate the original three GAS goals, provide open-ended descriptions of the status of those target behaviors, and complete the Autism Behavior Checklist (ABCT). Parents will complete the full battery of questionnaires administered at the Week 8 endpoint. Phase II: Controlled Trial The trial will consist of an 8-week intervention period. Participants will be assigned into the psychobiotic group and the control group. Gait analysis and subjective evaluations will be conducted at multiple time points, specifically, at Baseline and Week 8 (end of the first intervention period).
Trial Details
NCT Number NCT07118267
Lead Sponsor Mackay Memorial Hospital
Conditions
(from sponsor)
Autism Disorder
Related terms Autistic Disorder
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov