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NCT06789484: BABIES I
Characterization of the Gastrointestinal Microbiota in Newborn Infants
NA trial testing Probiotic in Healthy Infants in 40 participants. Currently enrolling.
30 October 2025
Quick facts
| Lead sponsor | Hvidovre University Hospital |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | other |
| Enrollment | 40 |
| Start date | 4 March 2025 |
| Primary completion | 30 October 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Probiotic
- Placebo
Conditions studied
- Healthy Infants — all drugs for Healthy Infants →
Sponsor
Hvidovre University Hospital
Who can join
Under 1 Day, any sex, with Healthy Infants. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The BABIES study is a single-center, randomized, double-blinded, placebo-controlled study in newborns with a 4-week intervention period from birth to 28 days of life followed by a 2-week follow-up period (Figure 1). The study will evaluate the seeding ability of supplementation with a probiotic strain. The aim is to investigate the recovery and engraftment of the probiotic strain in infant fecal samples after 4 weeks supplementation using a strain specific quantitative Polymerase Chain Reaction (qPCR).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06789484
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Healthy Infants
Currently open trials in the same condition.
- NCT07054216 — Probiotic for Infants · NA · recruiting
Other Hvidovre University Hospital trials
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 NCT06789484 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hvidovre University Hospital
- Last refreshed: 13 April 2025
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/NCT06789484.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing