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NCT03722550
Second Generation Human Milk Oligosaccharides Blend Study
NA trial testing Starter Infant Formula, Follow-up Formula, and Growing-up Milk Supplemented With a Blend of Five Human Milk Oligosaccharides in Healthy Infants in 789 participants. Completed in 19 January 2022.
5 November 2021
Quick facts
| Lead sponsor | Société des Produits Nestlé (SPN) |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | other |
| Enrollment | 789 |
| Start date | 19 September 2018 |
| Primary completion | 5 November 2021 |
| Estimated completion | 19 January 2022 |
| Sites | 34 locations across Poland, Bulgaria, Hungary |
Drugs / interventions tested
- Starter Infant Formula, Follow-up Formula, and Growing-up Milk Supplemented With a Blend of Five Human Milk Oligosaccharides
- Breast-feeding
- Standard Starter Infant Formula, Follow-up Formula, and Growing-up Milk
Conditions studied
- Healthy Infants — all drugs for Healthy Infants →
Sponsor
Société des Produits Nestlé (SPN) — full company profile →
Who can join
Adults 7 Days to 21 Days, any sex, with Healthy Infants. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of this trial is to show that infants fed these new formulas, containing a blend of 5 Human Milk Oligosaccharides (HMOs), allow for growth in line with infants fed formulas without HMOs. There will be different groups in the trial: three formula-fed groups and a breastfed group.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Infant Formula With a Specific Blend of Five Human Milk Oligosaccharides Drives the Gut Microbiota Development and Improves Gut Maturation Markers: A Randomized Controlled Trial.
Bosheva M, Tokodi I, Krasnow A, Pedersen HK, et al · · 2022 · cited 67× · PMID 35873420 · DOI 10.3389/fnut.2022.920362
Verify or expand the search:
- PubMed search for NCT03722550
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Healthy Infants
Currently open trials in the same condition.
- NCT07054216 — Probiotic for Infants · NA · recruiting
- NCT06789484 — Characterization of the Gastrointestinal Microbiota in Newborn Infants · NA · recruiting
Other Société des Produits Nestlé (SPN) trials
Trials by the same sponsor.
- NCT07312201 — Oral Nutritional Supplementation in Children With Growth Concerns · NA · not yet recruiting
- NCT07378111 — Vegetarian Tube Feed Study · NA · not yet recruiting
- NCT07439718 — The Effects of an Oral Nutritional Intervention on the Small Intestine Microbiome · NA · recruiting
- NCT07341464 — Acceptability and Tolerance Study of Bolus Tube Feed With Food Blends · NA · recruiting
- NCT07127198 — Tolerance and Appetite Reduction of a Nutritional Solution With Intragastric Gelation Properties · NA · completed
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 NCT03722550 (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 Société des Produits Nestlé (SPN)
- Last refreshed: 17 February 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/NCT03722550.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing