HMOs on Infant Gut Microbiota Modulation and Development of the Immune System in Healthy Infants
ConditionHealthy Infants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-28
SponsorUniversity of Aarhus
About this trial
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
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Premature birth
Trial design
Design model
Parallel
Treatments tested in this trial
Human Milk Oligosaccharides
Other interventionHuman Milk Oligosaccharides provided in a commercially available infant formula powder, fed daily ad libitum from enrollement to 6 months of age
Placebo
Other interventionAn identical commercially available infant formula powder without Human Milk Oligosaccharides, fed daily ad libitum from enrollement to 6 months of age
Treatment groups
334 Participants
are divided into 3 treatment groupsGroup A: Human Milk OligosaccharidesExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Group C: Breastfed reference groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Total abundance of bifidobacteria at 3 months of age
Abundance of fecal bifidobacteria measured by quantitative PCR
Time frame
Fecal samples collected at 3 monthsSecondary outcomes
1
Infant fecal pH at 3 months of age
Fecal pH measured in fecal water at 3 months of age
Time frame
Fecal samples collected at 3 months of ageOther outcomes
1
Infant growth
Infant weight, length, and head circumference will be aggregated to determine infant growth status
Time frame
1 week, 2 weeks, 1, 2, 3 and 6 months and 0-12 months2
Infant intestinal transit time
Intestinal transit time estimated by sweet-corn transit time through the gastrointestinal tract
Time frame
9 months and 12 months3
Frequency of Infections
Measured as episodes of respiratory and gastrointestinal infections within the first 6 months of age.
Time frame
1 week, 2 weeks, 1, 2, 3 and 6 months4
Infant crying and fussing
Measured as frequency/duration of crying and fussing assessed as parent-reported in the Infant Health Questionnaire
Time frame
1 week, 2 weeks, 1, 2, 3 and 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Aarhus
Lead sponsor
University of Copenhagen
Collaborator
Technical University of Denmark
Collaborator
Chr Hansen
Collaborator
Source ClinicalTrials.gov