Effects of human milk oligosaccharides on gut health and immune development in infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates how a mixture of human milk oligosaccharides (HMOs) influences the gut microbiota and immune system development in healthy infants. Participants will consume either the investigational product or a placebo for six months, while their parents will collect stool samples and report any gastrointestinal symptoms through an electronic questionnaire. The study will also include a reference group of breastfed infants undergoing similar monitoring without the investigational product. A total of 230 infants will be randomized into the intervention arms, with an additional 104 infants in the reference group.

Why it matters

Who can join: the full rules

Inclusion Criteria:

• All infants which parents has decided mode of feeding

Exclusion Criteria:

* Premature birth

Where it's running

• Aarhus University Hospital
  Aarhus, Denmark Recruiting
• Aarhus University Hospital
  Aarhus, Denmark Not yet recruiting

Study contacts

• Principal investigator: Lars H Pedersen, Professor, PhD, MD — Aarhus University Hospital
• Study coordinator: Diana Høtoft
• Email: diahoe@clin.au.dk
• Phone: +4523486730

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.