Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
| Technical University of Denmark | OTHER |
| Chr Hansen | INDUSTRY |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Human Milk Oligosaccharides | Experimental | Human Milk Oligosaccharides (HMO) |
|
| Placebo | Placebo Comparator | Identical commercial Infant Formula without human milk oligosaccharides, fed daily ad libitum from enrollement to 6 months of age |
|
| Breastfed reference group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total abundance of bifidobacteria at 3 months of age | Abundance of fecal bifidobacteria measured by quantitative PCR | Fecal samples collected at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Infant fecal pH at 3 months of age | Fecal pH measured in fecal water at 3 months of age | Fecal samples collected at 3 months of age |
| Measure | Description | Time Frame |
|---|---|---|
| Infant growth | Infant weight, length, and head circumference will be aggregated to determine infant growth status | 1 week, 2 weeks, 1, 2, 3 and 6 months and 0-12 months |
| Infant intestinal transit time |
Inclusion Criteria:
• All infants which parents has decided mode of feeding
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diana Høtoft | Contact | +4523486730 | diahoe@clin.au.dk |
| Name | Affiliation | Role |
|---|---|---|
| Lars H Pedersen, Professor, PhD, MD | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Not yet recruiting | Aarhus | 8200 | Denmark | ||
| Aarhus University Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A randomized, placebo controlled trial of term infants with a 6 months intervention phase and 6 months short-term follow-up phase.
Not provided
Not provided
Not provided
| Placebo | Other | An identical commercially available infant formula powder without Human Milk Oligosaccharides, fed daily ad libitum from enrollement to 6 months of age |
|
Intestinal transit time estimated by sweet-corn transit time through the gastrointestinal tract
| 9 months and 12 months |
| Frequency of Infections | Measured as episodes of respiratory and gastrointestinal infections within the first 6 months of age. | 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 | 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 | 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 | 1 week, 2 weeks, 1, 2, 3 and 6 months |
| Infant fecal immunoglobulins | Changes in fecal immunoglobulins from infant fecal samples | 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 | 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 | 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 | 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. | 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 | 3, 6 and 12 months |
| Characterization of Infant fecal cytokines profiles | Changes in pro-inflammatory and anti-inflammatory cytokines profiles measured in fecal samples | 1 week, 2 weeks, 1, 2, 3 and 6 months and 0-12 months |
| Recruiting |
| Aarhus |
| Denmark |
|