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Search / Trial NCT06631937

HMOs on Infant Gut Microbiota Modulation and Development of the Immune System in Healthy Infants

Launched by UNIVERSITY OF AARHUS · Oct 7, 2024

Trial Information

Current as of July 26, 2025

Recruiting

Keywords

Infants Gastrointestinal Microbiome Immune Development Gastrointestinal Well Being Infant Formula Fed

ClinConnect Summary

This clinical trial is studying how a special mixture of human milk oligosaccharides (HMOs) affects the gut bacteria and immune system development in healthy infants. The researchers want to understand how these changes might influence the short-term and long-term health of babies. To participate, infants must be healthy and their parents must have already decided how to feed them, whether by breast milk or formula. However, babies who were born prematurely cannot join the study.

Participants will take the investigational product or a placebo for six months and their parents will help by collecting stool samples from their diapers at home. Parents will also report any signs of tummy troubles or infections using an online questionnaire. There will be regular check-ups at the clinic where blood samples will be collected. The trial will involve about 334 babies in total, including a group of breastfed infants for comparison. The study aims to gather important information that could help improve infant health in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • • All infants which parents has decided mode of feeding
  • Exclusion Criteria:
  • Premature birth

About University Of Aarhus

The University of Aarhus, a prestigious research institution located in Denmark, is dedicated to advancing medical science through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, the university fosters an environment that encourages cutting-edge research and the development of novel therapeutic interventions. Committed to ethical standards and patient safety, the University of Aarhus aims to contribute to the global body of medical knowledge while enhancing healthcare outcomes through rigorous scientific inquiry and evidence-based practices.

Locations

Aarhus, , Denmark

Patients applied

0 patients applied

Trial Officials

Lars H Pedersen, Professor, PhD, MD

Principal Investigator

Aarhus University Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported