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NCT04942522
Application of Probiotic PS128 in Children With ASD
Phase 1 trial testing probiotics PS128 in Autism Spectrum Disorder in 80 participants. Status unknown.
6 June 2023
Quick facts
| Lead sponsor | Yan Hao |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 6 June 2021 |
| Primary completion | 6 June 2023 |
| Estimated completion | 6 October 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- probiotics PS128 — full drug profile →
- placebo (Microcrystalline cellulose ) — full drug profile →
Conditions studied
- Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →
Sponsor
Yan Hao — full company profile →
Who can join
Adults 2 to 5, any sex, with Autism Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to explore the role of probiotics PS128 in improving gastrointestinal dysfunction and core behavioral symptoms in children with ASD, and investigate the underlying etiological mechanisms of ASD.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
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 NCT04942522
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT04942522 (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 Yan Hao
- Last refreshed: 31 August 2022
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/NCT04942522.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing