Healthy Infants
Conditions
Keywords
infants, gastrointestinal microbiome, immune development, gastrointestinal well-being, infant formula fed
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.
Interventions
Human Milk Oligosaccharides provided in a commercially available infant formula powder, fed daily ad libitum from enrollement to 6 months of age
OTHERPlacebo
An identical commercially available infant formula powder without Human Milk Oligosaccharides, fed daily ad libitum from enrollement to 6 months of age
Sponsors
University of Copenhagen
Technical University of Denmark
Chr Hansen
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
A randomized, placebo controlled trial of term infants with a 6 months intervention phase and 6 months short-term follow-up phase.
Eligibility
Sex/Gender
ALL
Age
0 Days to 28 Days
Healthy volunteers
Yes
Inclusion criteria
• All infants which parents has decided mode of feeding
Exclusion criteria
* Premature birth
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total abundance of bifidobacteria at 3 months of age | Fecal samples collected at 3 months | Abundance of fecal bifidobacteria measured by quantitative PCR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infant fecal pH at 3 months of age | Fecal samples collected at 3 months of age | Fecal pH measured in fecal water at 3 months of age |
Other
| Measure | Time frame | Description |
|---|---|---|
| Infant growth | 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 |
| Infant intestinal transit time | 9 months and 12 months | Intestinal transit time estimated by sweet-corn transit time through the gastrointestinal tract |
| Frequency of Infections | 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. |
| Infant crying and fussing | 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 |
| General health status of infants | 0-12 months | General health status measured as number of health care visits and illness diagnosis |
| Characterization of Infant gut metabolome | 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 |
| Infant fecal immunoglobulins | 1 week, 2 weeks, 1, 2, 3 and 6 months and 0-12 months | Changes in fecal immunoglobulins from infant fecal samples |
| Infant blood immunoglobulins | 3, 6 and 12 months | Changes in immunoglobulins measured in dried blood spots |
| Characterization of the Infant gut microbiome composition | 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. |
| Characterization of Infant blood cytokine profiles | 3, 6 and 12 months | Changes in pro-inflammatory and anti-inflammatory cytokines profiles from dried blood spots |
| Characterization of Infant fecal cytokines profiles | 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 |
| Infant stool frequency | 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 |
| Characterization of the Infant blood metabolome | 3, 6 and 12 months | Characterization and changes of the Infant blood metabolome as assessed by targeted and untargeted metabolomics from dried blood spots |
Countries
Denmark
Contacts
Primary ContactDiana Høtoft
Outcome results
None listed