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Active, Not Recruiting

NCT Number: NCT05491161

The Motility Mother-Child Cohort

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Diet, Healthy Infant Development

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Copenhagen, Department of Nutrition, Exercise and Sports

Copenhagen, 1958, Denmark

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Longitudinal study

Other

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

Primary outcomes

  1. 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

  1. Infant gut metabolome

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

    Faecal metabolome as assessed by untargeted metabolomics

  2. Infant bowel habits

    Time frame: 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

  3. Infant intestinal transit time

    Time frame: 9 and 12 months

    Intestinal transit time estimated by sweet-corn transit time through the gastrointestinal tract

  4. Infant dietary patterns

    Time frame: Bi-weekly from birth until 12 months

    Changes in dietary patterns recorded using food frequency questionnaires

  5. Infant nutrient intake

    Time frame: 6, 9 and 12 months

    Assessment of dietary intake by 3-days 24-hour recall

  6. Total faecal bacteria

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

    Changes in total faecal bacteria as measured by quantitative PCR and flow cytometry

  7. Infant body weight

    Time frame: 0, 1, 3, 6, 9, and 12 months

    Changes in body weight from birth measured in gram (g) or kilogram (kg)

  8. Infant body length

    Time frame: 0, 1, 3, 6, 9, and 12 months

    Changes in body length measured in centimeters (cm)

  9. Infant growth

    Time frame: 0, 1, 3, 6, 9, and 12 months

    Infant weight and length will be aggregated to determine infant growth status

  10. Infant head circumference

    Time frame: 0, 1, 3, 6, 9, and 12 months

    Changes in head circumference measured in centimeters (cm)

  11. Infant fat stores

    Time frame: 3, 6, 9, and 12 months

    Changes in skin folds (triceps & subscapularis) measured with a skinfold caliper

  12. Infant body composition

    Time frame: 9 and 12 months

    Changes in body composition as measured by bioimpedance

  13. Infant urine metabolome

    Time frame: 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

Other outcomes

  1. Infant faecal short-chain fatty acids

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

    Changes in short-chain fatty acid production as measured by targeted metabolomics

  2. Infant blood metabolome

    Time frame: 3, 6, 9, and 12 months

    Changes in blood metabolome as assessed by untargeted metabolomics

  3. Maternal breast milk metabolome

    Time frame: 1, 2, 3, 4, 5, and 6 months postpartum

    Changes in breast milk metabolome as assessed by untargeted metabolomics

  4. Maternal breast milk human milk oligosaccharides

    Time frame: 1, 2, 3, 4, 5, and 6 months postpartum

    Changes in breast milk human milk oligosaccharides (HMOs) measured by metabolomics

  5. Infant blood appetite hormones

    Time frame: 3, 6, 9, and 12 months

    Concentrations of appetite hormones in blood

  6. Infant faecal proteome

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

    Changes in food- and microbiota-related antigens

  7. Infant faecal pH

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

    Changes in faecal pH

  8. Infant faecal oligosaccharide residues

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

    Changes in faecal oligosaccharide residues

  9. Infant faecal cytokines

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

    Changes in faecal cytokines

  10. Infant faecal immunoglobulins

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

    Changes in faecal immunoglobulins

  11. Infant faecal lipopolysaccharides

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

    Changes in faecal lipopolysaccharides (LPS)

  12. Infant blood immune cell profiles

    Time frame: 3, 6, 9, and 12 months

    Blood immune cell profiling

  13. Infant blood cytokine profiles

    Time frame: 3, 6, 9, and 12 months

    Blood cytokine profiling

  14. Infant gastrointestinal symptoms

    Time frame: Occurrence from birth until 12 months

    Gastrointestinal symptoms and related symptoms (fever, bloating, vomiting, diarrhea, constipation, irritability (crying time)) from birth through to 12 months of age

  15. Infant general health status

    Time frame: 3, 6, 9, and 12 months

    General health status of the infant in relation to occurrence of any illness and health care visits for sickness, use of antibiotics and medication.

  16. Maternal nutrient intake

    Time frame: Gestational week 35-37, 3 months and 9 months postpartum

    Assessment of dietary intake by 3-days 24-hours recall

  17. Infant oral microbiome

    Time frame: 3, 6, 9, and 12 months

    Changes in saliva microbiome measured by DNA/RNA sequencing of saliva samples from infants

  18. Infant oral metabolome

    Time frame: 3, 6, 9, and 12 months

    Changes in saliva metabolome measured by untargeted metabolomics

  19. Infant tooth development

    Time frame: 3, 6, 9, and 12 months

    Infant tooth development during the first year of life

  20. Infant sleep patterns

    Time frame: 3, 6, 9, and 12 months

    Infant sleep patterns during the first year of life based on the Brief Infant Sleep Questionnaire (BISQ)

  21. Infant motor development

    Time frame: 3, 6, 9, and 12 months

    Infant motor development as assessed by World Health Organization (WHO) assessment of motor milestones

  22. Mental well-being of infants

    Time frame: 9 and 12 months

    Infant mental health as assessed by the Copenhagen Infant Mental Health Screening (CIMHS) at 9 and 12 months of age

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Quadram Institute Bioscience
  • Technical University of Denmark
  • Technical University of Munich
  • University College Cork
  • University of Aarhus

Registry information

Official study title

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

Acronym: MOTILITY

Important dates

Study start
2022
Primary completion
2025
Study completion
2027
First posted
Aug 8, 2022
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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