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

University of Aarhus

Status: Enrolling

Conditions: Healthy Infants

Treatments: Other: Placebo; Other: Human Milk Oligosaccharides

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06631937

HND-IN-054

Details and patient eligibility

About

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.

Enrollment: 334 estimated patients

Sex: All

Ages: Under 28 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All infants which parents has decided mode of feeding

Exclusion criteria

• Premature birth

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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334 participants in 3 patient groups, including a placebo group

Human Milk Oligosaccharides

Experimental group

Description:

Human Milk Oligosaccharides (HMO)

Treatment:

Other: Human Milk Oligosaccharides

Placebo

Placebo Comparator group

Description:

Identical commercial Infant Formula without human milk oligosaccharides, fed daily ad libitum from enrollement to 6 months of age

Treatment:

Other: Placebo

Breastfed reference group

No Intervention group