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Clinical Trials/NCT05491161
NCT05491161
Active, Not Recruiting
N/A

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

University of Copenhagen1 site in 1 country250 target enrollmentAugust 22, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diet, Healthy
Sponsor
University of Copenhagen
Enrollment
250
Locations
1
Primary Endpoint
Infant gut microbiome composition
Status
Active, Not Recruiting
Last Updated
2 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
August 22, 2022
End Date
July 1, 2027
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Henrik Munch Roager

Associate Professor

University of Copenhagen

Eligibility Criteria

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

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:

Outcomes

Primary Outcomes

Infant gut microbiome composition

Time Frame: Faecal samples collected bi-weekly from birth until 12 months

Changes in gut microbiome measured by DNA/RNA sequencing of longitudinal faecal samples from infants

Secondary Outcomes

  • Infant growth(0, 1, 3, 6, 9, and 12 months)
  • Infant intestinal transit time(9 and 12 months)
  • Infant bowel habits(Bi-weekly from birth until 12 months)
  • Infant dietary patterns(Bi-weekly from birth until 12 months)
  • Infant body length(0, 1, 3, 6, 9, and 12 months)
  • Infant gut metabolome(Faecal samples collected bi-weekly from birth until 12 months)
  • Total faecal bacteria(Faecal samples collected bi-weekly from birth until 12 months)
  • Infant body weight(0, 1, 3, 6, 9, and 12 months)
  • Infant head circumference(0, 1, 3, 6, 9, and 12 months)
  • Infant body composition(9 and 12 months)
  • Infant urine metabolome(2 days, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months)
  • Infant nutrient intake(6, 9 and 12 months)
  • Infant fat stores(3, 6, 9, and 12 months)

Study Sites (1)

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