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NCT Number: NCT06631937

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

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.

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Key information

Conditions

Healthy Infants

Age range

0 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital, Aarhus, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All infants which parents has decided mode of feeding

Exclusion criteria

  • Premature birth

Treatment and study plan

Human Milk Oligosaccharides

Other

Human Milk Oligosaccharides provided in a commercially available infant formula powder, fed daily ad libitum from enrollement to 6 months of age

Placebo

Other

An identical commercially available infant formula powder without Human Milk Oligosaccharides, fed daily ad libitum from enrollement to 6 months of age

Primary outcomes

  1. Total abundance of bifidobacteria at 3 months of age

    Time frame: Fecal samples collected at 3 months

    Abundance of fecal bifidobacteria measured by quantitative PCR

Secondary outcomes

  1. Infant fecal pH at 3 months of age

    Time frame: Fecal samples collected at 3 months of age

    Fecal pH measured in fecal water at 3 months of age

Other outcomes

  1. Infant growth

    Time frame: 1 week, 2 weeks, 1, 2, 3 and 6 months and 0-12 months

    Infant weight, length, and head circumference will be aggregated to determine infant growth status

  2. Infant intestinal transit time

    Time frame: 9 months and 12 months

    Intestinal transit time estimated by sweet-corn transit time through the gastrointestinal tract

  3. Frequency of Infections

    Time frame: 1 week, 2 weeks, 1, 2, 3 and 6 months

    Measured as episodes of respiratory and gastrointestinal infections within the first 6 months of age.

  4. Infant crying and fussing

    Time frame: 1 week, 2 weeks, 1, 2, 3 and 6 months

    Measured as frequency/duration of crying and fussing assessed as parent-reported in the Infant Health Questionnaire

  5. General health status of infants

    Time frame: 0-12 months

    General health status measured as number of health care visits and illness diagnosis

  6. Infant stool frequency

    Time frame: 1 week, 2 weeks, 1, 2, 3 and 6 months

    Changes in stool frequency and consistency measured from birth through to 6 months of age assessed as parent-reported in the Infant Health Questionnaire

  7. Infant fecal immunoglobulins

    Time frame: 1 week, 2 weeks, 1, 2, 3 and 6 months and 0-12 months

    Changes in fecal immunoglobulins from infant fecal samples

  8. Infant blood immunoglobulins

    Time frame: 3, 6 and 12 months

    Changes in immunoglobulins measured in dried blood spots

  9. Characterization of Infant gut metabolome

    Time frame: 1 week, 2 weeks, 1, 2, 3, 6, 9 and 12 months

    Characterization and changes in the Infant fecal metabolome as assessed by targeted and untargeted metabolomics

  10. Characterization of the Infant blood metabolome

    Time frame: 3, 6 and 12 months

    Characterization and changes of the Infant blood metabolome as assessed by targeted and untargeted metabolomics from dried blood spots

  11. Characterization of the Infant gut microbiome composition

    Time frame: 1 week, 2 weeks, 1, 2, 3, 6, 9 and 12 months

    Changes in gut microbiome composition analyzed by DNA/RNA sequencing of fecal samples.

  12. Characterization of Infant blood cytokine profiles

    Time frame: 3, 6 and 12 months

    Changes in pro-inflammatory and anti-inflammatory cytokines profiles from dried blood spots

  13. Characterization of Infant fecal cytokines profiles

    Time frame: 1 week, 2 weeks, 1, 2, 3 and 6 months and 0-12 months

    Changes in pro-inflammatory and anti-inflammatory cytokines profiles measured in fecal samples

Study contacts

Contact information is provided by the study sponsor or research team.

Diana Høtoft

CONTACT

[email protected]

+4523486730

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Chr Hansen
  • Technical University of Denmark
  • University of Copenhagen

Registry information

Official study 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

Acronym: BELIEF

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Oct 8, 2024
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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