The Motility Mother-Child Cohort

Diet, Healthy Clinical Trial

— MOTILITY  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05491161
• Other study ID #: M241
• Status: Active, not recruiting
• Start date: August 22, 2022
• Est. completion date: July 1, 2027

Study information

• Verified date: December 2023
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: July 1, 2027
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Diet, Healthy
• Infant Development

Intervention

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

Locations

Country	Name	City	State
Denmark	University of Copenhagen, Department of Nutrition, Exercise and Sports	Copenhagen

Sponsors (6)

Lead Sponsor	Collaborator
University of Copenhagen	Quadram Institute Bioscience, Technical University of Denmark, Technical University of Munich, University College Cork, University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Infant faecal short-chain fatty acids	Changes in short-chain fatty acid production as measured by targeted metabolomics	Faecal samples collected bi-weekly from birth until 12 months
Other	Infant blood metabolome	Changes in blood metabolome as assessed by untargeted metabolomics	3, 6, 9, and 12 months
Other	Maternal breast milk metabolome	Changes in breast milk metabolome as assessed by untargeted metabolomics	1, 2, 3, 4, 5, and 6 months postpartum
Other	Maternal breast milk human milk oligosaccharides	Changes in breast milk human milk oligosaccharides (HMOs) measured by metabolomics	1, 2, 3, 4, 5, and 6 months postpartum
Other	Infant blood appetite hormones	Concentrations of appetite hormones in blood	3, 6, 9, and 12 months
Other	Infant faecal proteome	Changes in food- and microbiota-related antigens	Faecal samples collected bi-weekly from birth until 12 months
Other	Infant faecal pH	Changes in faecal pH	Faecal samples collected bi-weekly from birth until 12 months
Other	Infant faecal oligosaccharide residues	Changes in faecal oligosaccharide residues	Faecal samples collected bi-weekly from birth until 12 months
Other	Infant faecal cytokines	Changes in faecal cytokines	Faecal samples collected bi-weekly from birth until 12 months
Other	Infant faecal immunoglobulins	Changes in faecal immunoglobulins	Faecal samples collected bi-weekly from birth until 12 months
Other	Infant faecal lipopolysaccharides	Changes in faecal lipopolysaccharides (LPS)	Faecal samples collected bi-weekly from birth until 12 months
Other	Infant blood immune cell profiles	Blood immune cell profiling	3, 6, 9, and 12 months
Other	Infant blood cytokine profiles	Blood cytokine profiling	3, 6, 9, and 12 months
Other	Infant gastrointestinal symptoms	Gastrointestinal symptoms and related symptoms (fever, bloating, vomiting, diarrhea, constipation, irritability (crying time)) from birth through to 12 months of age	Occurrence from birth until 12 months
Other	Infant general health status	General health status of the infant in relation to occurrence of any illness and health care visits for sickness, use of antibiotics and medication.	3, 6, 9, and 12 months
Other	Maternal nutrient intake	Assessment of dietary intake by 3-days 24-hours recall	Gestational week 35-37, 3 months and 9 months postpartum
Other	Infant oral microbiome	Changes in saliva microbiome measured by DNA/RNA sequencing of saliva samples from infants	3, 6, 9, and 12 months
Other	Infant oral metabolome	Changes in saliva metabolome measured by untargeted metabolomics	3, 6, 9, and 12 months
Other	Infant tooth development	Infant tooth development during the first year of life	3, 6, 9, and 12 months
Other	Infant sleep patterns	Infant sleep patterns during the first year of life based on the Brief Infant Sleep Questionnaire (BISQ)	3, 6, 9, and 12 months
Other	Infant motor development	Infant motor development as assessed by World Health Organization (WHO) assessment of motor milestones	3, 6, 9, and 12 months
Other	Mental well-being of infants	Infant mental health as assessed by the Copenhagen Infant Mental Health Screening (CIMHS) at 9 and 12 months of age	9 and 12 months
Primary	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	Infant gut metabolome	Faecal metabolome as assessed by untargeted metabolomics	Faecal samples collected bi-weekly from birth until 12 months
Secondary	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
Secondary	Infant intestinal transit time	Intestinal transit time estimated by sweet-corn transit time through the gastrointestinal tract	9 and 12 months
Secondary	Infant dietary patterns	Changes in dietary patterns recorded using food frequency questionnaires	Bi-weekly from birth until 12 months
Secondary	Infant nutrient intake	Assessment of dietary intake by 3-days 24-hour recall	6, 9 and 12 months
Secondary	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
Secondary	Infant body weight	Changes in body weight from birth measured in gram (g) or kilogram (kg)	0, 1, 3, 6, 9, and 12 months
Secondary	Infant body length	Changes in body length measured in centimeters (cm)	0, 1, 3, 6, 9, and 12 months
Secondary	Infant growth	Infant weight and length will be aggregated to determine infant growth status	0, 1, 3, 6, 9, and 12 months
Secondary	Infant head circumference	Changes in head circumference measured in centimeters (cm)	0, 1, 3, 6, 9, and 12 months
Secondary	Infant fat stores	Changes in skin folds (triceps & subscapularis) measured with a skinfold caliper	3, 6, 9, and 12 months
Secondary	Infant body composition	Changes in body composition as measured by bioimpedance	9 and 12 months
Secondary	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