An observational study in Diet, Healthy and Infant Development, sponsored by University of Copenhagen. Active, not recruiting at 1 site in Denmark. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-05.
Sponsored by University of Copenhagen · Observational
The overall aim of the project is to investigate how bowel habits and nutrition in early life relate to the infant gut microbiome and metabolome from birth to 1 year of age. By unravelling links between these factors in early life, we might be able to identify new putative mechanisms by which diet via microbiota-dependent pathways affects intestinal motility in early life. Furtermore, it will be explored how the development of the gut microbiome associates with the child´s development.
A cohort including 125 mother/infant pairs will be established with the purpose of following the infants' progression in diet, bowel habits, gut and oral microbiome, gut and oral metabolome, physiological and mental development from birth to 12 months of age. This will be possible by longitudinal collection and analysis of biological samples and data from birth until 1 year of age.
The primary hypotheses to be tested are that early dietary patterns (composition, complexity, quality, and timing) and bowel habits (stool frequency, consistency, and transit time) are associated with the development of the infant gut microbial composition and metabolism.
The secondary hypotheses to be tested are that the development of the infant gut microbial composition and metabolism associate with growth (body weight, length, body mass index, head circumference, body composition), development of the immune system as reflected in the gut (fecal cytokines, immunoglobulins, lipopolysaccharide, antigens) as well as the systemic circulation (blood cytokines, immune cells), host metabolism (blood metabolome, appetite hormones, urine metabolome), and physical development (sleep, motor development, mental development).
The tertiary hypotheses to be tested are that the establishment and development of the infant gut microbiome is associated with external environmental factors (household, siblings, maternal diet, maternal fecal microbiome, maternal physical activity, birth conditions, and perinatal factors), and internal factors (infant oral cavity, tooth development, use of pacifier).
University of Copenhagen is the lead sponsor of 465 studies on the registry; 63 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Healthy population
Mothers Inclusion Criteria:
Mothers Exclusion Criteria:
Infants Inclusion Criteria:
- Gestational age at birth: 36 weeks or later
Infants Exclusion Criteria:
- Severe chronic illness
Longitudinal study following infant development from birth to 1 year of age
Infant gut microbiome composition
Changes in gut microbiome measured by DNA/RNA sequencing of longitudinal faecal samples from infants
Time frame: Faecal samples collected bi-weekly from birth until 12 months
Infant gut metabolome
Faecal metabolome as assessed by untargeted metabolomics
Time frame: Faecal samples collected bi-weekly from birth until 12 months
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
Time frame: Bi-weekly from birth until 12 months
Infant intestinal transit time
Intestinal transit time estimated by sweet-corn transit time through the gastrointestinal tract
Time frame: 9 and 12 months
Infant dietary patterns
Changes in dietary patterns recorded using food frequency questionnaires
Time frame: Bi-weekly from birth until 12 months
Infant nutrient intake
Assessment of dietary intake by 3-days 24-hour recall
Time frame: 6, 9 and 12 months
Total faecal bacteria
Changes in total faecal bacteria as measured by quantitative PCR and flow cytometry
Time frame: Faecal samples collected bi-weekly from birth until 12 months
Infant body weight
Changes in body weight from birth measured in gram (g) or kilogram (kg)
Time frame: 0, 1, 3, 6, 9, and 12 months
Infant body length
Changes in body length measured in centimeters (cm)
Time frame: 0, 1, 3, 6, 9, and 12 months
Infant growth
Infant weight and length will be aggregated to determine infant growth status
Time frame: 0, 1, 3, 6, 9, and 12 months
Infant head circumference
Changes in head circumference measured in centimeters (cm)
Time frame: 0, 1, 3, 6, 9, and 12 months
Infant fat stores
Changes in skin folds (triceps \& subscapularis) measured with a skinfold caliper
Time frame: 3, 6, 9, and 12 months
Infant body composition
Changes in body composition as measured by bioimpedance
Time frame: 9 and 12 months
Infant urine metabolome
Changes in urine metabolome as assessed by untargeted metabolomics
Time frame: 2 days, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months
Infant faecal short-chain fatty acids
Changes in short-chain fatty acid production as measured by targeted metabolomics
Time frame: Faecal samples collected bi-weekly from birth until 12 months
Infant blood metabolome
Changes in blood metabolome as assessed by untargeted metabolomics
Time frame: 3, 6, 9, and 12 months
Maternal breast milk metabolome
Changes in breast milk metabolome as assessed by untargeted metabolomics
Time frame: 1, 2, 3, 4, 5, and 6 months postpartum
Maternal breast milk human milk oligosaccharides
Changes in breast milk human milk oligosaccharides (HMOs) measured by metabolomics
Time frame: 1, 2, 3, 4, 5, and 6 months postpartum
Infant blood appetite hormones
Concentrations of appetite hormones in blood
Time frame: 3, 6, 9, and 12 months
Infant faecal proteome
Changes in food- and microbiota-related antigens
Time frame: Faecal samples collected bi-weekly from birth until 12 months
Infant faecal pH
Changes in faecal pH
Time frame: Faecal samples collected bi-weekly from birth until 12 months
Infant faecal oligosaccharide residues
Changes in faecal oligosaccharide residues
Time frame: Faecal samples collected bi-weekly from birth until 12 months
Infant faecal cytokines
Changes in faecal cytokines
Time frame: Faecal samples collected bi-weekly from birth until 12 months
Infant faecal immunoglobulins
Changes in faecal immunoglobulins
Time frame: Faecal samples collected bi-weekly from birth until 12 months
Infant faecal lipopolysaccharides
Changes in faecal lipopolysaccharides (LPS)
Time frame: Faecal samples collected bi-weekly from birth until 12 months
Infant blood immune cell profiles
Blood immune cell profiling
Time frame: 3, 6, 9, and 12 months
Infant blood cytokine profiles
Blood cytokine profiling
Time frame: 3, 6, 9, and 12 months
Infant gastrointestinal symptoms
Gastrointestinal symptoms and related symptoms (fever, bloating, vomiting, diarrhea, constipation, irritability (crying time)) from birth through to 12 months of age
Time frame: Occurrence from birth until 12 months
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.
Time frame: 3, 6, 9, and 12 months
Maternal nutrient intake
Assessment of dietary intake by 3-days 24-hours recall
Time frame: Gestational week 35-37, 3 months and 9 months postpartum
Infant oral microbiome
Changes in saliva microbiome measured by DNA/RNA sequencing of saliva samples from infants
Time frame: 3, 6, 9, and 12 months
Infant oral metabolome
Changes in saliva metabolome measured by untargeted metabolomics
Time frame: 3, 6, 9, and 12 months
Infant tooth development
Infant tooth development during the first year of life
Time frame: 3, 6, 9, and 12 months
Infant sleep patterns
Infant sleep patterns during the first year of life based on the Brief Infant Sleep Questionnaire (BISQ)
Time frame: 3, 6, 9, and 12 months
Infant motor development
Infant motor development as assessed by World Health Organization (WHO) assessment of motor milestones
Time frame: 3, 6, 9, and 12 months
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
Time frame: 9 and 12 months
This study is active, not recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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