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

Not Applicable

Recruiting

• Conditions: Healthy Infants
• Interventions: Other: Human Milk Oligosaccharides; Other: Placebo

• Registration Number: NCT06631937
• Lead Sponsor: University of Aarhus

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-20
• Study First Submitted QC: 2024-10-07
• Study First Posted: 2024-10-08
• Status Verified: 2024-11
• Study Start: 2024-11-05
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-11
• Primary Completion: 2026-12
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 334

Inclusion Criteria

• All infants which parents has decided mode of feeding

Exclusion Criteria

• Premature birth

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Human Milk Oligosaccharides	Human Milk Oligosaccharides	Human Milk Oligosaccharides (HMO)
Placebo	Placebo	Identical commercial Infant Formula without human milk oligosaccharides, fed daily ad libitum from enrollement to 6 months of age

Primary Outcome Measures

Name	Time	Method
Total abundance of bifidobacteria at 3 months of age	Fecal samples collected at 3 months	Abundance of fecal bifidobacteria measured by quantitative PCR

Secondary Outcome Measures

Name	Time	Method
Infant fecal pH at 3 months of age	Fecal samples collected at 3 months of age	Fecal pH measured in fecal water at 3 months of age

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark