The Motility Mother-Child Cohort

N/AActive Not RecruitingNCT05491161

University of Copenhagen250 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

250

Conditions

Diet, Healthy Infant Development

Interventions

Longitudinal studyOTHER

Longitudinal study following infant development from birth to 1 year of age

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Copenhagen, Department of Nutrition, Exercise and Sports

Copenhagen, Denmark

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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