Actively Recruiting

Phase Not Applicable
Age: 0Days - 28Days
All Genders
Healthy Volunteers
NCT06631937

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

Led by University of Aarhus · Updated on 2024-11-12

334

Participants Needed

2

Research Sites

142 weeks

Total Duration

On this page

Sponsors

U

University of Aarhus

Lead Sponsor

U

University of Copenhagen

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 0Days - 28Days
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Infant's parents have decided the mode of feeding
Not Eligible

You will not qualify if you...

  • Premature birth

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Aarhus University Hospital

Aarhus, Denmark, 8200

Not Yet Recruiting

2

Aarhus University Hospital

Aarhus, Denmark

Actively Recruiting

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Research Team

D

Diana Høtoft

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

3

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