Clinical trial NCT05491161: The Motility Mother-Child Cohort
Official title: The Motility Mother-Child Cohort - Gut Microbes, Diet and Bowel Habits in Early Life
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Diet, Healthy
Infant Development
Keywords: Microbiome
Metabolomics
Nutrition
Bowel habits
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: University College Cork
name: Technical University of Munich
name: Quadram Institute Bioscience
name: University of Aarhus
name: Technical University of Denmark
First posted: 2022-08-08
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy population

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Infant gut microbiome composition
timeFrame: Faecal samples collected bi-weekly from birth until 12 months
Secondary outcomes:
measure: Infant gut metabolome
timeFrame: Faecal samples collected bi-weekly from birth until 12 months
measure: Infant bowel habits
timeFrame: Bi-weekly from birth until 12 months
measure: Infant intestinal transit time
timeFrame: 9 and 12 months
measure: Infant dietary patterns
timeFrame: Bi-weekly from birth until 12 months
measure: Infant nutrient intake
timeFrame: 6, 9 and 12 months
measure: Total faecal bacteria
timeFrame: Faecal samples collected bi-weekly from birth until 12 months
measure: Infant body weight
timeFrame: 0, 1, 3, 6, 9, and 12 months
measure: Infant body length
timeFrame: 0, 1, 3, 6, 9, and 12 months
measure: Infant growth
timeFrame: 0, 1, 3, 6, 9, and 12 months
measure: Infant head circumference
timeFrame: 0, 1, 3, 6, 9, and 12 months
measure: Infant fat stores
timeFrame: 3, 6, 9, and 12 months
measure: Infant body composition
timeFrame: 9 and 12 months
measure: Infant urine metabolome
timeFrame: 2 days, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months
Other outcomes:
measure: Infant faecal short-chain fatty acids
timeFrame: Faecal samples collected bi-weekly from birth until 12 months
measure: Infant blood metabolome
timeFrame: 3, 6, 9, and 12 months
measure: Maternal breast milk metabolome
timeFrame: 1, 2, 3, 4, 5, and 6 months postpartum
measure: Maternal breast milk human milk oligosaccharides
timeFrame: 1, 2, 3, 4, 5, and 6 months postpartum
measure: Infant blood appetite hormones
timeFrame: 3, 6, 9, and 12 months
measure: Infant faecal proteome
timeFrame: Faecal samples collected bi-weekly from birth until 12 months
measure: Infant faecal pH
timeFrame: Faecal samples collected bi-weekly from birth until 12 months
measure: Infant faecal oligosaccharide residues
timeFrame: Faecal samples collected bi-weekly from birth until 12 months
measure: Infant faecal cytokines
timeFrame: Faecal samples collected bi-weekly from birth until 12 months
measure: Infant faecal immunoglobulins
timeFrame: Faecal samples collected bi-weekly from birth until 12 months
measure: Infant faecal lipopolysaccharides
timeFrame: Faecal samples collected bi-weekly from birth until 12 months
measure: Infant blood immune cell profiles
timeFrame: 3, 6, 9, and 12 months
measure: Infant blood cytokine profiles
timeFrame: 3, 6, 9, and 12 months
measure: Infant gastrointestinal symptoms
timeFrame: Occurrence from birth until 12 months
measure: Infant general health status
timeFrame: 3, 6, 9, and 12 months
measure: Maternal nutrient intake
timeFrame: Gestational week 35-37, 3 months and 9 months postpartum
measure: Infant oral microbiome
timeFrame: 3, 6, 9, and 12 months
measure: Infant oral metabolome
timeFrame: 3, 6, 9, and 12 months
measure: Infant tooth development
timeFrame: 3, 6, 9, and 12 months
measure: Infant sleep patterns
timeFrame: 3, 6, 9, and 12 months
measure: Infant motor development
timeFrame: 3, 6, 9, and 12 months
measure: Mental well-being of infants
timeFrame: 9 and 12 months
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen, Department of Nutrition, Exercise and Sports
Study officials:
References: