Effects of human milk oligosaccharides on gut health and immune development in infants
The Effect of Human Milk Oligosaccharides on Infant Gut Microbiota Modulation, Development of the Immune System and Health Later in Life: the BELIEF Study
This study is testing whether a special mix of human milk sugars can improve gut health and help the immune system develop in healthy infants.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 334 (estimated) |
| Ages | 0 Days to 28 Days |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 2 sites (Aarhus and 1 other locations) |
| Trial ID | NCT06631937 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy infants whose parents have chosen their mode of feeding.
Not a fit: Infants who were born prematurely may not benefit from this study due to their unique health considerations.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of how HMOs contribute to infant gut health and immune system maturation, potentially leading to improved health outcomes.
How similar studies have performed: Other studies have shown promising results regarding the impact of HMOs on infant health, suggesting this approach has potential.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: • All infants which parents has decided mode of feeding Exclusion Criteria: * Premature birth
Where this trial is running
Aarhus and 1 other locations
- Aarhus University Hospital — Aarhus, Denmark (Not_yet_recruiting)
- Aarhus University Hospital — Aarhus, Denmark (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.