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NCT06126185

Open-label Pilot Study Synbiotic Treatment for Autism Spectrum Disorder

Completed NA Last updated 2 April 2026
What this trial tests

NA trial testing 12-week course of synbiotic in Autism Spectrum Disorder in 30 participants. Completed in 31 July 2025.

Timeline
1 December 2023
Primary endpoint
31 December 2024
31 July 2025

Quick facts

Lead sponsorChinese University of Hong Kong
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment30
Start date1 December 2023
Primary completion31 December 2024
Estimated completion31 July 2025
Sites1 location across Hong Kong

Drugs / interventions tested

Conditions studied

Sponsor

Chinese University of Hong Kong

Who can join

Adults 2 to 12, any sex, with Autism Spectrum Disorder or Anxiety. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objective of this study is to conduct a open-label pilot study evaluating the feasibility, tolerability and preliminary efficacy of a 12-week course of synbiotic in improving anxiety symptoms in children with ASD. The investigators hypothesise that the course of synbiotic will feasible and tolerable, and that there will be a reduction in anxiety symptoms in ASD children after the 12-week course of synbiotic.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. A novel synbiotic (SCM06) for anxiety and sensory hyperresponsiveness in children with autism spectrum disorder: an open-label pilot study.
    Wong OWH, Xu Z, Chan SSM, Mo FYM, et al · · 2026 · cited 2× · PMID 41535300 · DOI 10.1038/s41522-025-00902-8
  2. The endocannabinoidome-gut microbiome-brain axis as a novel therapeutic target for autism spectrum disorder.
    Campanale A, Siniscalco D, Di Marzo V. · · 2025 · cited 2× · PMID 40605060 · DOI 10.1186/s12929-025-01145-7

Verify or expand the search:

Other recruiting trials for Autism Spectrum Disorder

Currently open trials in the same condition.

Other Chinese University of Hong Kong trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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