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NCT06126185
Open-label Pilot Study Synbiotic Treatment for Autism Spectrum Disorder
NA trial testing 12-week course of synbiotic in Autism Spectrum Disorder in 30 participants. Completed in 31 July 2025.
31 December 2024
Quick facts
| Lead sponsor | Chinese University of Hong Kong |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 December 2023 |
| Primary completion | 31 December 2024 |
| Estimated completion | 31 July 2025 |
| Sites | 1 location across Hong Kong |
Drugs / interventions tested
- 12-week course of synbiotic
Conditions studied
- Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →
- Anxiety — all drugs for Anxiety →
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):
-
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 -
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:
- PubMed search for NCT06126185
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06126185 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chinese University of Hong Kong
- Last refreshed: 2 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06126185.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing