The Motility Mother-Child Cohort

NCT05491161 | Active Not Recruiting

• 1 other identifier: M241
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Diet, Healthy; Infant Development

Keywords

Microbiome; Metabolomics; Nutrition; Bowel habits

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Infant gut metabolome

  Faecal samples collected bi-weekly from birth until 12 months

• Infant bowel habits

  Bi-weekly from birth until 12 months

• Infant intestinal transit time

  9 and 12 months

• Infant dietary patterns

  Bi-weekly from birth until 12 months

• Infant nutrient intake

  6, 9 and 12 months

Other Outcomes (22)

• Infant faecal short-chain fatty acids

  Faecal samples collected bi-weekly from birth until 12 months

• Infant blood metabolome

  3, 6, 9, and 12 months

• Maternal breast milk metabolome

  1, 2, 3, 4, 5, and 6 months postpartum

Interventions

Longitudinal study OTHER

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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy population

You may qualify if:

• 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

You may not qualify if:

• 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
• \- Gestational age at birth: 36 weeks or later
• \- Severe chronic illness

Sponsors & Collaborators

• University of Copenhagen: lead
• University College Cork: collaborator
• Technical University of Munich: collaborator
• Quadram Institute Bioscience: collaborator
• University of Aarhus: collaborator
• Technical University of Denmark: collaborator

Study Sites (1)

University of Copenhagen, Department of Nutrition, Exercise and Sports

Copenhagen, 1958, Denmark

Location

Related Publications (1)

• 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.

  PMID: 40533209 DERIVED

MeSH Terms

Interventions

Longitudinal Studies

Intervention Hierarchy (Ancestors)

Cohort Studies; Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 8, 2022
• Study Start: August 22, 2022
• Primary Completion: January 1, 2025
• Study Completion (Estimated): July 1, 2027
• Last Updated: December 5, 2023

Record last verified: 2023-12

Locations

DK (1)