Safety and tolerability of oral supplementation with human milk oligosaccharides in preterm infants

Safety and tolerability of oral supplementation with human milk oligosaccharides in preterm infants - HMO1-Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00038371

Enrollment

Registered

2025-11-25

Start date

2025-12-13

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Infants

Interventions

Group 1: This is an exploratory study on the safety and tolerability of oral supplementation with human milk oligosaccharides. The infants receive a mixture of breast milk/donor milk and a standardize

Eligibility

Sex/Gender

All

Age

No minimum to 32 Weeks

Inclusion criteria

Inclusion criteria: Gestational age at birth < 32+0 weeks and/or birth weight under 1500g, consent of the parents/guardians

Exclusion criteria

Exclusion criteria: Gastrointestinal malformations, serious congenital anomalies and chromosomal abnormalities

Design outcomes

Primary

Measure	Time frame
Safety and tolerability. To assess this, the following parameters are documented and monitored: Occurrence of adverse events such as gastrointestinal intolerance, necrotizing enterocolitis, sepsis, and death. Laboratory parameters are also used for clinical monitoring.	—

Secondary

Measure	Time frame
Observation of stools, weight gain per day and duration of enteral feeding progression until complete feeding. Exploratory analysis of the microbiome and glycosylation. In addition, a small subgroup of three to five study participants will be examined to determine whether components of breast milk, particularly human milk oligosaccharides, can be detected in the blood following enteral intake, and whether these components are related to the composition of breast milk and glycosylation-related parameters in stool.	—

Measure

Time frame

Observation of stools, weight gain per day and duration of enteral feeding progression until complete feeding. Exploratory analysis of the microbiome and glycosylation. In addition, a small subgroup of three to five study participants will be examined to determine whether components of breast milk, particularly human milk oligosaccharides, can be detected in the blood following enteral intake, and whether these components are related to the composition of breast milk and glycosylation-related parameters in stool.

—

Countries

Germany

Contacts

Public ContactSven Wellmann

Klinik und Poliklinik für Kinder- und Jugendmedizin der Universität Regensburg, KinderUniKlinik Ostbayern (KUNO), Klinik St. Hedwig, Barmherzige Brüder Regensburg

neonatologie@barmherzige-regensburg.de+49 941 369- 5401

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026