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The Motility Mother-Child Cohort

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05491161
Acronym
MOTILITY
Enrollment
250
Registered
2022-08-08
Start date
2022-08-22
Completion date
2027-07-01
Last updated
2023-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diet, Healthy, Infant Development

Keywords

Microbiome, Metabolomics, Nutrition, Bowel habits

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).

Interventions

OTHERLongitudinal study

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

Sponsors

University College Cork
CollaboratorOTHER
Technical University of Munich
CollaboratorOTHER
Quadram Institute Bioscience
CollaboratorOTHER
University of Aarhus
CollaboratorOTHER
Technical University of Denmark
CollaboratorOTHER
University of Copenhagen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Infant gut microbiome compositionFaecal samples collected bi-weekly from birth until 12 monthsChanges in gut microbiome measured by DNA/RNA sequencing of longitudinal faecal samples from infants

Secondary

MeasureTime frameDescription
Infant bowel habitsBi-weekly from birth until 12 monthsChanges in bowel habits as measured by stool frequency, stool consistency and stool colour from birth through to 12 months of age
Infant intestinal transit time9 and 12 monthsIntestinal transit time estimated by sweet-corn transit time through the gastrointestinal tract
Infant dietary patternsBi-weekly from birth until 12 monthsChanges in dietary patterns recorded using food frequency questionnaires
Infant nutrient intake6, 9 and 12 monthsAssessment of dietary intake by 3-days 24-hour recall
Total faecal bacteriaFaecal samples collected bi-weekly from birth until 12 monthsChanges in total faecal bacteria as measured by quantitative PCR and flow cytometry
Infant body weight0, 1, 3, 6, 9, and 12 monthsChanges in body weight from birth measured in gram (g) or kilogram (kg)
Infant gut metabolomeFaecal samples collected bi-weekly from birth until 12 monthsFaecal metabolome as assessed by untargeted metabolomics
Infant growth0, 1, 3, 6, 9, and 12 monthsInfant weight and length will be aggregated to determine infant growth status
Infant head circumference0, 1, 3, 6, 9, and 12 monthsChanges in head circumference measured in centimeters (cm)
Infant fat stores3, 6, 9, and 12 monthsChanges in skin folds (triceps & subscapularis) measured with a skinfold caliper
Infant body composition9 and 12 monthsChanges in body composition as measured by bioimpedance
Infant urine metabolome2 days, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 monthsChanges in urine metabolome as assessed by untargeted metabolomics
Infant body length0, 1, 3, 6, 9, and 12 monthsChanges in body length measured in centimeters (cm)

Other

MeasureTime frameDescription
Infant general health status3, 6, 9, and 12 monthsGeneral health status of the infant in relation to occurrence of any illness and health care visits for sickness, use of antibiotics and medication.
Maternal nutrient intakeGestational week 35-37, 3 months and 9 months postpartumAssessment of dietary intake by 3-days 24-hours recall
Infant oral microbiome3, 6, 9, and 12 monthsChanges in saliva microbiome measured by DNA/RNA sequencing of saliva samples from infants
Infant oral metabolome3, 6, 9, and 12 monthsChanges in saliva metabolome measured by untargeted metabolomics
Infant blood immune cell profiles3, 6, 9, and 12 monthsBlood immune cell profiling
Infant sleep patterns3, 6, 9, and 12 monthsInfant sleep patterns during the first year of life based on the Brief Infant Sleep Questionnaire (BISQ)
Infant motor development3, 6, 9, and 12 monthsInfant motor development as assessed by World Health Organization (WHO) assessment of motor milestones
Mental well-being of infants9 and 12 monthsInfant mental health as assessed by the Copenhagen Infant Mental Health Screening (CIMHS) at 9 and 12 months of age
Infant tooth development3, 6, 9, and 12 monthsInfant tooth development during the first year of life
Infant blood cytokine profiles3, 6, 9, and 12 monthsBlood cytokine profiling
Infant faecal short-chain fatty acidsFaecal samples collected bi-weekly from birth until 12 monthsChanges in short-chain fatty acid production as measured by targeted metabolomics
Infant blood metabolome3, 6, 9, and 12 monthsChanges in blood metabolome as assessed by untargeted metabolomics
Maternal breast milk metabolome1, 2, 3, 4, 5, and 6 months postpartumChanges in breast milk metabolome as assessed by untargeted metabolomics
Maternal breast milk human milk oligosaccharides1, 2, 3, 4, 5, and 6 months postpartumChanges in breast milk human milk oligosaccharides (HMOs) measured by metabolomics
Infant blood appetite hormones3, 6, 9, and 12 monthsConcentrations of appetite hormones in blood
Infant faecal proteomeFaecal samples collected bi-weekly from birth until 12 monthsChanges in food- and microbiota-related antigens
Infant faecal pHFaecal samples collected bi-weekly from birth until 12 monthsChanges in faecal pH
Infant faecal oligosaccharide residuesFaecal samples collected bi-weekly from birth until 12 monthsChanges in faecal oligosaccharide residues
Infant faecal cytokinesFaecal samples collected bi-weekly from birth until 12 monthsChanges in faecal cytokines
Infant faecal immunoglobulinsFaecal samples collected bi-weekly from birth until 12 monthsChanges in faecal immunoglobulins
Infant faecal lipopolysaccharidesFaecal samples collected bi-weekly from birth until 12 monthsChanges in faecal lipopolysaccharides (LPS)
Infant gastrointestinal symptomsOccurrence from birth until 12 monthsGastrointestinal symptoms and related symptoms (fever, bloating, vomiting, diarrhea, constipation, irritability (crying time)) from birth through to 12 months of age

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026