NCT03513744 is a NA clinical trial of human milk oligosaccharides in Infant Nutrition, sponsored by Jennewein Biotechnologie GmbH.

Who is sponsoring NCT03513744?

NCT03513744 is sponsored by Jennewein Biotechnologie GmbH.

What drugs are being tested in NCT03513744?

Interventions in NCT03513744: human milk oligosaccharides.

What condition does NCT03513744 study?

NCT03513744 studies Infant Nutrition.

Is NCT03513744 still recruiting?

NCT03513744 is currently completed. Last updated 16 October 2023.

Last reviewed 2023-10-16 · How we verify

NCT03513744

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study Evaluating Growth and Tolerance of Infant Formula Containing HMOs

Completed NA Last updated 16 October 2023

What this trial tests

NA trial testing human milk oligosaccharides in Infant Nutrition in 340 participants. Completed in 5 April 2021.

Timeline

19 November 2018

Primary endpoint
3 March 2021

5 April 2021

Quick facts

Lead sponsor	Jennewein Biotechnologie GmbH
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	340
Start date	19 November 2018
Primary completion	3 March 2021
Estimated completion	5 April 2021
Sites	9 locations across Italy, Germany, Spain

Drugs / interventions tested

human milk oligosaccharides

Conditions studied

Infant Nutrition — all drugs for Infant Nutrition →

Sponsor

Jennewein Biotechnologie GmbH

Who can join

Adults 1 Day to 13 Days, any sex, with Infant Nutrition. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary objective of this clinical study is to investigate the suitability of an infant formula containing five different human milk oligosaccharides to support normal physical growth (evaluated per weight gain), in comparison with infant formula without human milk oligosaccharides, when the formula is fed as the sole source of nutrition.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Clinical Evaluation of 16-Week Supplementation with 5HMO-Mix in Healthy-Term Human Infants to Determine Tolerability, Safety, and Effect on Growth.
Parschat K, Melsaether C, Jäpelt KR, Jennewein S. · · 2021 · cited 67× · PMID 34445031 · DOI 10.3390/nu13082871
Infant Formula Supplemented with Five Human Milk Oligosaccharides Shifts the Fecal Microbiome of Formula-Fed Infants Closer to That of Breastfed Infants.
Holst AQ, Myers P, Rodríguez-García P, Hermes GDA, et al · · 2023 · cited 21× · PMID 37513505 · DOI 10.3390/nu15143087
Human Milk Oligosaccharides: Decoding Their Structural Variability, Health Benefits, and the Evolution of Infant Nutrition.
Duman H, Bechelany M, Karav S. · · 2024 · cited 18× · PMID 39796552 · DOI 10.3390/nu17010118

Verify or expand the search:

Other recruiting trials for Infant Nutrition

Currently open trials in the same condition.

NCT05119166 — International Milk Composition (IMiC) Consortium · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03513744 (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 Jennewein Biotechnologie GmbH
Last refreshed: 16 October 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/NCT03513744.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing