The Motility Mother-Child Cohort

Active, not recruiting

• Conditions: Infant Development; Diet, Healthy

• Registration Number: NCT05491161
• Lead Sponsor: University of Copenhagen

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).

Study Timeline

• Study First Submitted: 2022-08-03
• Study First Submitted QC: 2022-08-04
• Study First Posted: 2022-08-08
• Study Start: 2022-08-22
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-04
• Last Update Posted: 2023-12-05
• Primary Completion: 2025-01-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 250

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Infant gut microbiome composition	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 Outcome Measures

Name	Time	Method
Infant growth	0, 1, 3, 6, 9, and 12 months	Infant weight and length will be aggregated to determine infant growth status
Infant intestinal transit time	9 and 12 months	Intestinal transit time estimated by sweet-corn transit time through the gastrointestinal tract
Infant bowel habits	Bi-weekly from birth until 12 months	Changes in bowel habits as measured by stool frequency, stool consistency and stool colour from birth through to 12 months of age
Infant dietary patterns	Bi-weekly from birth until 12 months	Changes in dietary patterns recorded using food frequency questionnaires
Infant body length	0, 1, 3, 6, 9, and 12 months	Changes in body length measured in centimeters (cm)
Infant gut metabolome	Faecal samples collected bi-weekly from birth until 12 months	Faecal metabolome as assessed by untargeted metabolomics
Total faecal bacteria	Faecal samples collected bi-weekly from birth until 12 months	Changes in total faecal bacteria as measured by quantitative PCR and flow cytometry
Infant body weight	0, 1, 3, 6, 9, and 12 months	Changes in body weight from birth measured in gram (g) or kilogram (kg)
Infant head circumference	0, 1, 3, 6, 9, and 12 months	Changes in head circumference measured in centimeters (cm)
Infant body composition	9 and 12 months	Changes in body composition as measured by bioimpedance
Infant urine metabolome	2 days, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months	Changes in urine metabolome as assessed by untargeted metabolomics
Infant nutrient intake	6, 9 and 12 months	Assessment of dietary intake by 3-days 24-hour recall
Infant fat stores	3, 6, 9, and 12 months	Changes in skin folds (triceps \& subscapularis) measured with a skinfold caliper

Trial Locations

Locations (1)

University of Copenhagen, Department of Nutrition, Exercise and Sports; 🇩🇰 Copenhagen, Denmark