The Motility Mother-Child Cohort

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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The Motility Mother-Child Cohort - Gut Microbes, Diet and Bowel Habits in Early Life

Conditions
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Diet, Healthy, Infant Development

Intervention / Treatment
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* Other: Longitudinal study


Participation Criteria
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Eligibility Criteria
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Mothers Inclusion Criteria: Age: 18-40 years of age at inclusion Speaking Danish (since all written and oral information will be in Danish) Willing to store their child's biological samples in a small closed container in their own freezer at home Mothers Exclusion Criteria: Gestational age more than 34 weeks at time of recruitment Diagnosed with gestational diabetes during this current pregnancy Diagnosed with preeclampsia during this current pregnancy Diagnosed with any severe or chronic diseases* Expecting triplets or higher order of multiple pregnancy Concurrent participation in another study Not capable of following the examinations according to the investigator´s instructions Infants Inclusion Criteria: - Gestational age at birth: 36 weeks or later Infants Exclusion Criteria: - Severe chronic illness

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Longitudinal study|Longitudinal study following infant development from birth to 1 year of age|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant gut metabolome | Faecal metabolome as assessed by untargeted metabolomics | 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 | Bi-weekly from birth until 12 months | 
| Infant intestinal transit time | Intestinal transit time estimated by sweet-corn transit time through the gastrointestinal tract | 9 and 12 months | 
| Infant dietary patterns | Changes in dietary patterns recorded using food frequency questionnaires | Bi-weekly from birth until 12 months | 
| Infant nutrient intake | Assessment of dietary intake by 3-days 24-hour recall | 6, 9 and 12 months | 
| 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 | 
| Infant body weight | Changes in body weight from birth measured in gram (g) or kilogram (kg) | 0, 1, 3, 6, 9, and 12 months | 
| Infant body length | Changes in body length measured in centimeters (cm) | 0, 1, 3, 6, 9, and 12 months | 
| Infant growth | Infant weight and length will be aggregated to determine infant growth status | 0, 1, 3, 6, 9, and 12 months | 
| Infant head circumference | Changes in head circumference measured in centimeters (cm) | 0, 1, 3, 6, 9, and 12 months | 
| Infant fat stores | Changes in skin folds (triceps & subscapularis) measured with a skinfold caliper | 3, 6, 9, and 12 months | 
| Infant body composition | Changes in body composition as measured by bioimpedance | 9 and 12 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microbiome, Metabolomics, Nutrition, Bowel habits