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

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

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

Sponsors & Collaborators

• University of Copenhagen

  collaborator OTHER

• Technical University of Denmark

  collaborator OTHER

• Chr Hansen

  collaborator INDUSTRY

• University of Aarhus

  lead OTHER

Principal Investigators

• Lars H Pedersen, Professor, PhD, MD · Aarhus University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

0 Days

Max Age

28 Days

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-11-05

Primary Completion

2026-12-31

Completion

2027-08-31

Countries

• Denmark

Study Locations