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

NCT06631937 | Recruiting

• 1 other identifier: HND-IN-054
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy Infants

Keywords

infants; gastrointestinal microbiome; immune development; gastrointestinal well-being; infant formula fed

Outcome Measures

Primary Outcomes (1)

• Total abundance of bifidobacteria at 3 months of age

  Abundance of fecal bifidobacteria measured by quantitative PCR

  Fecal samples collected at 3 months

Secondary Outcomes (1)

• Infant fecal pH at 3 months of age

  Fecal samples collected at 3 months of age

Other Outcomes (13)

• Infant growth

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

• Infant intestinal transit time

  9 months and 12 months

• Frequency of Infections

  1 week, 2 weeks, 1, 2, 3 and 6 months

Study Arms (3)

Human Milk Oligosaccharides

EXPERIMENTAL

Human Milk Oligosaccharides (HMO)

Other: Human Milk Oligosaccharides

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Breastfed reference group

NO INTERVENTION

Interventions

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

Human Milk Oligosaccharides

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• All infants which parents has decided mode of feeding

You may not qualify if:

• Premature birth

Sponsors & Collaborators

• University of Aarhus: lead
• University of Copenhagen: collaborator
• Technical University of Denmark: collaborator
• Chr Hansen: collaborator

Study Sites (2)

Aarhus University Hospital

Aarhus, 8200, Denmark

NOT YET RECRUITING

Aarhus University Hospital

Aarhus, Denmark

RECRUITING

Study Officials

• Lars H Pedersen, Professor, PhD, MD

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana Høtoft

CONTACT

+4523486730; diahoe@clin.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized, placebo controlled trial of term infants with a 6 months intervention phase and 6 months short-term follow-up phase.

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: October 8, 2024
• Study Start: November 5, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)