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NCT05151601
Combined Human Milk Oligosaccharides (HMOs) and Probiotics Intervention for Children With Autism
NA trial testing Experimental in Autism Spectrum Disorder in 60 participants. Status unknown.
16 April 2023
Quick facts
| Lead sponsor | The University of Queensland |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 17 May 2022 |
| Primary completion | 16 April 2023 |
| Estimated completion | 31 December 2023 |
| Sites | 1 location across Australia |
Drugs / interventions tested
- Experimental — full drug profile →
- Placebo
Conditions studied
- Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →
- Neurodevelopmental Disorders — all drugs for Neurodevelopmental Disorders →
- Anxiety — all drugs for Anxiety →
Sponsor
The University of Queensland
Who can join
Adults 5 to 12, any sex, with Autism Spectrum Disorder or Neurodevelopmental Disorders. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This research project will investigate if a supplement containing a unique combination of prebiotics and probiotics can influence behaviour in children diagnosed with autism spectrum disorder. The study will use a combination of human milk oligosaccharides (HMOs, prebiotics) and probiotics as an oral powder.This clinical trial will have two consecutive phases. Phase 1A is an 8-week randomised, double-blinded, placebo-controlled trial. Participants will be recruited and randomised (1:1) to receive either the investigational product (treatment group, n=30) or the placebo (control group, n=30). Phase 1B is an 8-week open-label study. All participants that complete Phase 1A will move into Phase 1B (n=60). This allows all participants to receive the investigational product and will provide additional information on increased duration of treatment.
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 NCT05151601
- 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 NCT05151601 (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 The University of Queensland
- Last refreshed: 28 June 2023
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/NCT05151601.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing