Clinical trial NCT06631937: HMOs on Infant Gut Microbiota Modulation and Development of the Immune System in Healthy Infants
Official title: The Effect of Human Milk Oligosaccharides on Infant Gut Microbiota Modulation, Development of the Immune System and Health Later in Life: the BELIEF Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Infants
Keywords: infants
gastrointestinal microbiome
immune development
gastrointestinal well-being
infant formula fed
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Technical University of Denmark
name: Chr Hansen
First posted: 2024-10-08
Enrollment: 334
Sex: ALL
Minimum age (years): 0
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, placebo controlled trial of term infants with a 6 months intervention phase and 6 months short-term follow-up phase.
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

• All infants which parents has decided mode of feeding

Exclusion Criteria:

* Premature birth

Primary outcomes:
measure: Total abundance of bifidobacteria at 3 months of age
timeFrame: Fecal samples collected at 3 months
Secondary outcomes:
measure: Infant fecal pH at 3 months of age
timeFrame: Fecal samples collected at 3 months of age
Other outcomes:
measure: Infant growth
timeFrame: 1 week, 2 weeks, 1, 2, 3 and 6 months and 0-12 months
measure: Infant intestinal transit time
timeFrame: 9 months and 12 months
measure: Frequency of Infections
timeFrame: 1 week, 2 weeks, 1, 2, 3 and 6 months
measure: Infant crying and fussing
timeFrame: 1 week, 2 weeks, 1, 2, 3 and 6 months
measure: General health status of infants
timeFrame: 0-12 months
measure: Infant stool frequency
timeFrame: 1 week, 2 weeks, 1, 2, 3 and 6 months
measure: Infant fecal immunoglobulins
timeFrame: 1 week, 2 weeks, 1, 2, 3 and 6 months and 0-12 months
measure: Infant blood immunoglobulins
timeFrame: 3, 6 and 12 months
measure: Characterization of Infant gut metabolome
timeFrame: 1 week, 2 weeks, 1, 2, 3, 6, 9 and 12 months
measure: Characterization of the Infant blood metabolome
timeFrame: 3, 6 and 12 months
measure: Characterization of the Infant gut microbiome composition
timeFrame: 1 week, 2 weeks, 1, 2, 3, 6, 9 and 12 months
measure: Characterization of Infant blood cytokine profiles
timeFrame: 3, 6 and 12 months
measure: Characterization of Infant fecal cytokines profiles
timeFrame: 1 week, 2 weeks, 1, 2, 3 and 6 months and 0-12 months
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Lars H Pedersen, Professor, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: