NCT06631937

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 334 (estimated)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 0 Days – 28 Days
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to learn how a mixture of human milk oligosaccharides impacts the development of the infant microbiota, the immune maturation and how the interaction between the microbiota and immune maturation may impact both short and long term health of the infant. The participants will: * Consume the investigational products (active/placebo) for 6 months * Legal guardians/parents to the participant to collect stool samples from the diapers at home * Legal guardians/parents to the participant to report gastrointestinal symptoms, signs of infections in an electronic questionnaire * Visit the clinic for checkups and dried blood sample collection For reference, a group of breastfed infants will be included. They will undergo the same procedures apart from consuming the investigational product (active/placebo). 230 participants (115 in each intervention arm) will be randomized to an intervention and 104 participants will be recruited for the reference group, giving a total sample size of 334 participants. The intervention trial will be reported in two steps, first step covering the intervention phase from birth to 6 months; and step two includes both the intervention phase (0-6 months) and the follow-up period from 6-12 months. Informed consents for the possibility to preform long-term follow-up will be obtained.

Conditions

• Healthy Infants

Interventions

Type	Name	Description
OTHER	Human Milk Oligosaccharides	Human Milk Oligosaccharides provided in a commercially available infant formula powder, fed daily ad libitum from enrollement to 6 months of age
OTHER	Placebo	An identical commercially available infant formula powder without Human Milk Oligosaccharides, fed daily ad libitum from enrollement to 6 months of age

Timeline

• Start date: 2024-11-05
• Primary completion: 2026-12-01
• Completion: 2027-08-01
• First posted: 2024-10-08
• Last updated: 2024-11-12

Locations

2 sites across 1 country: Denmark