Diet, HealthyMOTILITYNCT05491161
The Motility Mother-Child Cohort
An observational study of Diet, Healthy and Infant Development, run by University of Copenhagen at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy, Infant Development
- What is being tested?
- Longitudinal study
- How many people
- 250 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Aug 2022to 1 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy population
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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
University of Copenhagen, Department of Nutrition, Exercise and Sports
Copenhagen, 1958
About this study
Official title: The Motility Mother-Child Cohort - Gut Microbes, Diet and Bowel Habits in Early Life
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.
Read the 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).
- Conditions
- Diet, Healthy, Infant Development
- Being tested
- Longitudinal study
- Keywords
- Microbiome, Metabolomics, Nutrition, Bowel habits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Longitudinal studyOther
Longitudinal study following infant development from birth to 1 year of age
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant gut microbiome composition
Changes in gut microbiome measured by DNA/RNA sequencing of longitudinal faecal samples from infants
Measured: Faecal samples collected bi-weekly from birth until 12 months
Secondary outcomes (13)
Infant gut metabolome
Faecal metabolome as assessed by untargeted metabolomics
Measured: Faecal samples collected bi-weekly from birth until 12 months
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
Measured: Bi-weekly from birth until 12 months
Infant intestinal transit time
Intestinal transit time estimated by sweet-corn transit time through the gastrointestinal tract
Measured: 9 and 12 months
Infant dietary patterns
Changes in dietary patterns recorded using food frequency questionnaires
Measured: Bi-weekly from birth until 12 months
Infant nutrient intake
Assessment of dietary intake by 3-days 24-hour recall
Measured: 6, 9 and 12 months
Total faecal bacteria
Changes in total faecal bacteria as measured by quantitative PCR and flow cytometry
Measured: Faecal samples collected bi-weekly from birth until 12 months
Infant body weight
Changes in body weight from birth measured in gram (g) or kilogram (kg)
Measured: 0, 1, 3, 6, 9, and 12 months
Infant body length
Changes in body length measured in centimeters (cm)
Measured: 0, 1, 3, 6, 9, and 12 months
Infant growth
Infant weight and length will be aggregated to determine infant growth status
Measured: 0, 1, 3, 6, 9, and 12 months
Infant head circumference
Changes in head circumference measured in centimeters (cm)
Measured: 0, 1, 3, 6, 9, and 12 months
Infant fat stores
Changes in skin folds (triceps \& subscapularis) measured with a skinfold caliper
Measured: 3, 6, 9, and 12 months
Infant body composition
Changes in body composition as measured by bioimpedance
Measured: 9 and 12 months
Infant urine metabolome
Changes in urine metabolome as assessed by untargeted metabolomics
Measured: 2 days, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start22 Aug 2022
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diet, HealthyStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- University College Cork, Technical University of Munich, Quadram Institute Bioscience, University of Aarhus, Technical University of Denmark
- Responsible party
- Principal investigator, Henrik Munch Roager, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491161
- Sponsor's protocol ID
- M241
- Acronym
- MOTILITY
- Status last verified
- Dec 2023
- First submitted
- 3 Aug 2022
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40533209
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Motility Mother-Child Cohort - Gut Microbes, Diet and Bowel Habits in Early Life
- ClinicalTrials.gov ID
- NCT05491161
- Acronym / sponsor ID
- MOTILITY / M241
- Conditions
- Diet, Healthy, Infant Development
- Keywords
- Microbiome, Metabolomics, Nutrition, Bowel habits
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- University College Cork, Technical University of Munich, Quadram Institute Bioscience, University of Aarhus, Technical University of Denmark
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 8 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy population
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Longitudinal studyLongitudinal study following infant development from birth to 1 year of age | Other | – |
Primary outcome
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
13 secondary outcomes
Infant gut metabolome
Time frame: Faecal samples collected bi-weekly from birth until 12 months
Infant bowel habits
Time frame: Bi-weekly from birth until 12 months
Infant intestinal transit time
Time frame: 9 and 12 months
Infant dietary patterns
Time frame: Bi-weekly from birth until 12 months
Infant nutrient intake
Time frame: 6, 9 and 12 months
Total faecal bacteria
Time frame: Faecal samples collected bi-weekly from birth until 12 months
Infant body weight
Time frame: 0, 1, 3, 6, 9, and 12 months
Infant body length
Time frame: 0, 1, 3, 6, 9, and 12 months
Infant growth
Time frame: 0, 1, 3, 6, 9, and 12 months
Infant head circumference
Time frame: 0, 1, 3, 6, 9, and 12 months
Infant fat stores
Time frame: 3, 6, 9, and 12 months
Infant body composition
Time frame: 9 and 12 months
Infant urine metabolome
Time frame: 2 days, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Derived from this study: PubMed 40533209Stolberg-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diet, Healthy and Infant Development, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant gut microbiome composition (time frame: Faecal samples collected bi-weekly from birth until 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05491161, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023; AzTrials last refreshed its copy on 6 Nov 2026.