An interventional study of Human Milk Oligosaccharides and Placebo in Healthy Infants, sponsored by University of Aarhus. Recruiting at 2 sites in Denmark. Open to participants aged 0 Days to 28 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-12.
Sponsored by University of Aarhus · Not applicable, Interventional, and Other
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:
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.
University of Aarhus is the lead sponsor of 1,299 studies on the registry; 189 are open to participants now.
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Exclusion Criteria:
Human Milk Oligosaccharides (HMO)
Other: Human Milk Oligosaccharides
Identical commercial Infant Formula without human milk oligosaccharides, fed daily ad libitum from enrollement to 6 months of age
Other: Placebo
Human Milk Oligosaccharides provided in a commercially available infant formula powder, fed daily ad libitum from enrollement to 6 months of age
An identical commercially available infant formula powder without Human Milk Oligosaccharides, fed daily ad libitum from enrollement to 6 months of age
Total abundance of bifidobacteria at 3 months of age
Abundance of fecal bifidobacteria measured by quantitative PCR
Time frame: Fecal samples collected at 3 months
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 age
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 months
Infant intestinal transit time
Intestinal transit time estimated by sweet-corn transit time through the gastrointestinal tract
Time frame: 9 months and 12 months
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 months
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 months
General health status of infants
General health status measured as number of health care visits and illness diagnosis
Time frame: 0-12 months
Infant stool frequency
Changes in stool frequency and consistency measured from birth through to 6 months of age assessed as parent-reported in the Infant Health Questionnaire
Time frame: 1 week, 2 weeks, 1, 2, 3 and 6 months
Infant fecal immunoglobulins
Changes in fecal immunoglobulins from infant fecal samples
Time frame: 1 week, 2 weeks, 1, 2, 3 and 6 months and 0-12 months
Infant blood immunoglobulins
Changes in immunoglobulins measured in dried blood spots
Time frame: 3, 6 and 12 months
Characterization of Infant gut metabolome
Characterization and changes in the Infant fecal metabolome as assessed by targeted and untargeted metabolomics
Time frame: 1 week, 2 weeks, 1, 2, 3, 6, 9 and 12 months
Characterization of the Infant blood metabolome
Characterization and changes of the Infant blood metabolome as assessed by targeted and untargeted metabolomics from dried blood spots
Time frame: 3, 6 and 12 months
Characterization of the Infant gut microbiome composition
Changes in gut microbiome composition analyzed by DNA/RNA sequencing of fecal samples.
Time frame: 1 week, 2 weeks, 1, 2, 3, 6, 9 and 12 months
Characterization of Infant blood cytokine profiles
Changes in pro-inflammatory and anti-inflammatory cytokines profiles from dried blood spots
Time frame: 3, 6 and 12 months
Characterization of Infant fecal cytokines profiles
Changes in pro-inflammatory and anti-inflammatory cytokines profiles measured in fecal samples
Time frame: 1 week, 2 weeks, 1, 2, 3 and 6 months and 0-12 months
Plan to share: No
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