The Motility Mother-Child Cohort

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-22

Study Completion Date

2027-07-01

Brief Summary

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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

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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).

Conditions

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Diet, Healthy Infant Development

Keywords

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Microbiome Metabolomics Nutrition Bowel habits

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Longitudinal study

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

Intervention Type OTHER

Eligibility Criteria

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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

\- Gestational age at birth: 36 weeks or later

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

\- Severe chronic illness

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Henrik Munch Roager

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Copenhagen, Department of Nutrition, Exercise and Sports

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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Stolberg-Mathieu G, Mikkelsen LS, Gottlieb AD, Molgaard C, Roager HM. The MOTILITY Mother-Child Cohort: a Danish prospective longitudinal cohort study of the infant gut microbiome, nutrition and bowel habits - a study protocol. BMJ Open. 2025 Jun 18;15(6):e094965. doi: 10.1136/bmjopen-2024-094965.

Reference Type DERIVED

PMID: 40533209 (View on PubMed)

Other Identifiers

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M241

Identifier Type: -

Identifier Source: org_study_id