Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Infant faecal short-chain fatty acids |
Changes in short-chain fatty acid production as measured by targeted metabolomics |
Faecal samples collected bi-weekly from birth until 12 months |
|
Other |
Infant blood metabolome |
Changes in blood metabolome as assessed by untargeted metabolomics |
3, 6, 9, and 12 months |
|
Other |
Maternal breast milk metabolome |
Changes in breast milk metabolome as assessed by untargeted metabolomics |
1, 2, 3, 4, 5, and 6 months postpartum |
|
Other |
Maternal breast milk human milk oligosaccharides |
Changes in breast milk human milk oligosaccharides (HMOs) measured by metabolomics |
1, 2, 3, 4, 5, and 6 months postpartum |
|
Other |
Infant blood appetite hormones |
Concentrations of appetite hormones in blood |
3, 6, 9, and 12 months |
|
Other |
Infant faecal proteome |
Changes in food- and microbiota-related antigens |
Faecal samples collected bi-weekly from birth until 12 months |
|
Other |
Infant faecal pH |
Changes in faecal pH |
Faecal samples collected bi-weekly from birth until 12 months |
|
Other |
Infant faecal oligosaccharide residues |
Changes in faecal oligosaccharide residues |
Faecal samples collected bi-weekly from birth until 12 months |
|
Other |
Infant faecal cytokines |
Changes in faecal cytokines |
Faecal samples collected bi-weekly from birth until 12 months |
|
Other |
Infant faecal immunoglobulins |
Changes in faecal immunoglobulins |
Faecal samples collected bi-weekly from birth until 12 months |
|
Other |
Infant faecal lipopolysaccharides |
Changes in faecal lipopolysaccharides (LPS) |
Faecal samples collected bi-weekly from birth until 12 months |
|
Other |
Infant blood immune cell profiles |
Blood immune cell profiling |
3, 6, 9, and 12 months |
|
Other |
Infant blood cytokine profiles |
Blood cytokine profiling |
3, 6, 9, and 12 months |
|
Other |
Infant gastrointestinal symptoms |
Gastrointestinal symptoms and related symptoms (fever, bloating, vomiting, diarrhea, constipation, irritability (crying time)) from birth through to 12 months of age |
Occurrence from birth until 12 months |
|
Other |
Infant general health status |
General health status of the infant in relation to occurrence of any illness and health care visits for sickness, use of antibiotics and medication. |
3, 6, 9, and 12 months |
|
Other |
Maternal nutrient intake |
Assessment of dietary intake by 3-days 24-hours recall |
Gestational week 35-37, 3 months and 9 months postpartum |
|
Other |
Infant oral microbiome |
Changes in saliva microbiome measured by DNA/RNA sequencing of saliva samples from infants |
3, 6, 9, and 12 months |
|
Other |
Infant oral metabolome |
Changes in saliva metabolome measured by untargeted metabolomics |
3, 6, 9, and 12 months |
|
Other |
Infant tooth development |
Infant tooth development during the first year of life |
3, 6, 9, and 12 months |
|
Other |
Infant sleep patterns |
Infant sleep patterns during the first year of life based on the Brief Infant Sleep Questionnaire (BISQ) |
3, 6, 9, and 12 months |
|
Other |
Infant motor development |
Infant motor development as assessed by World Health Organization (WHO) assessment of motor milestones |
3, 6, 9, and 12 months |
|
Other |
Mental well-being of infants |
Infant mental health as assessed by the Copenhagen Infant Mental Health Screening (CIMHS) at 9 and 12 months of age |
9 and 12 months |
|
Primary |
Infant gut microbiome composition |
Changes in gut microbiome measured by DNA/RNA sequencing of longitudinal faecal samples from infants |
Faecal samples collected bi-weekly from birth until 12 months |
|
Secondary |
Infant gut metabolome |
Faecal metabolome as assessed by untargeted metabolomics |
Faecal samples collected bi-weekly from birth until 12 months |
|
Secondary |
Infant bowel habits |
Changes in bowel habits as measured by stool frequency, stool consistency and stool colour from birth through to 12 months of age |
Bi-weekly from birth until 12 months |
|
Secondary |
Infant intestinal transit time |
Intestinal transit time estimated by sweet-corn transit time through the gastrointestinal tract |
9 and 12 months |
|
Secondary |
Infant dietary patterns |
Changes in dietary patterns recorded using food frequency questionnaires |
Bi-weekly from birth until 12 months |
|
Secondary |
Infant nutrient intake |
Assessment of dietary intake by 3-days 24-hour recall |
6, 9 and 12 months |
|
Secondary |
Total faecal bacteria |
Changes in total faecal bacteria as measured by quantitative PCR and flow cytometry |
Faecal samples collected bi-weekly from birth until 12 months |
|
Secondary |
Infant body weight |
Changes in body weight from birth measured in gram (g) or kilogram (kg) |
0, 1, 3, 6, 9, and 12 months |
|
Secondary |
Infant body length |
Changes in body length measured in centimeters (cm) |
0, 1, 3, 6, 9, and 12 months |
|
Secondary |
Infant growth |
Infant weight and length will be aggregated to determine infant growth status |
0, 1, 3, 6, 9, and 12 months |
|
Secondary |
Infant head circumference |
Changes in head circumference measured in centimeters (cm) |
0, 1, 3, 6, 9, and 12 months |
|
Secondary |
Infant fat stores |
Changes in skin folds (triceps & subscapularis) measured with a skinfold caliper |
3, 6, 9, and 12 months |
|
Secondary |
Infant body composition |
Changes in body composition as measured by bioimpedance |
9 and 12 months |
|
Secondary |
Infant urine metabolome |
Changes in urine metabolome as assessed by untargeted metabolomics |
2 days, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months |
|