Ignite Creation Date:
2025-12-24 @ 12:44 PM
Ignite Modification Date:
2025-12-28 @ 8:19 AM
Study NCT ID:
NCT05491161
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-05
First Post:
2022-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Motility Mother-Child Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008137', 'term': 'Longitudinal Studies'}], 'ancestors': [{'id': 'D015331', 'term': 'Cohort Studies'}, {'id': 'D016021', 'term': 'Epidemiologic Studies'}, {'id': 'D016020', 'term': 'Epidemiologic Study Characteristics'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-04', 'studyFirstSubmitDate': '2022-08-03', 'studyFirstSubmitQcDate': '2022-08-04', 'lastUpdatePostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Infant faecal short-chain fatty acids', 'timeFrame': 'Faecal samples collected bi-weekly from birth until 12 months', 'description': 'Changes in short-chain fatty acid production as measured by targeted metabolomics'}, {'measure': 'Infant blood metabolome', 'timeFrame': '3, 6, 9, and 12 months', 'description': 'Changes in blood metabolome as assessed by untargeted metabolomics'}, {'measure': 'Maternal breast milk metabolome', 'timeFrame': '1, 2, 3, 4, 5, and 6 months postpartum', 'description': 'Changes in breast milk metabolome as assessed by untargeted metabolomics'}, {'measure': 'Maternal breast milk human milk oligosaccharides', 'timeFrame': '1, 2, 3, 4, 5, and 6 months postpartum', 'description': 'Changes in breast milk human milk oligosaccharides (HMOs) measured by metabolomics'}, {'measure': 'Infant blood appetite hormones', 'timeFrame': '3, 6, 9, and 12 months', 'description': 'Concentrations of appetite hormones in blood'}, {'measure': 'Infant faecal proteome', 'timeFrame': 'Faecal samples collected bi-weekly from birth until 12 months', 'description': 'Changes in food- and microbiota-related antigens'}, {'measure': 'Infant faecal pH', 'timeFrame': 'Faecal samples collected bi-weekly from birth until 12 months', 'description': 'Changes in faecal pH'}, {'measure': 'Infant faecal oligosaccharide residues', 'timeFrame': 'Faecal samples collected bi-weekly from birth until 12 months', 'description': 'Changes in faecal oligosaccharide residues'}, {'measure': 'Infant faecal cytokines', 'timeFrame': 'Faecal samples collected bi-weekly from birth until 12 months', 'description': 'Changes in faecal cytokines'}, {'measure': 'Infant faecal immunoglobulins', 'timeFrame': 'Faecal samples collected bi-weekly from birth until 12 months', 'description': 'Changes in faecal immunoglobulins'}, {'measure': 'Infant faecal lipopolysaccharides', 'timeFrame': 'Faecal samples collected bi-weekly from birth until 12 months', 'description': 'Changes in faecal lipopolysaccharides (LPS)'}, {'measure': 'Infant blood immune cell profiles', 'timeFrame': '3, 6, 9, and 12 months', 'description': 'Blood immune cell profiling'}, {'measure': 'Infant blood cytokine profiles', 'timeFrame': '3, 6, 9, and 12 months', 'description': 'Blood cytokine profiling'}, {'measure': 'Infant gastrointestinal symptoms', 'timeFrame': 'Occurrence from birth until 12 months', 'description': 'Gastrointestinal symptoms and related symptoms (fever, bloating, vomiting, diarrhea, constipation, irritability (crying time)) from birth through to 12 months of age'}, {'measure': 'Infant general health status', 'timeFrame': '3, 6, 9, and 12 months', 'description': 'General health status of the infant in relation to occurrence of any illness and health care visits for sickness, use of antibiotics and medication.'}, {'measure': 'Maternal nutrient intake', 'timeFrame': 'Gestational week 35-37, 3 months and 9 months postpartum', 'description': 'Assessment of dietary intake by 3-days 24-hours recall'}, {'measure': 'Infant oral microbiome', 'timeFrame': '3, 6, 9, and 12 months', 'description': 'Changes in saliva microbiome measured by DNA/RNA sequencing of saliva samples from infants'}, {'measure': 'Infant oral metabolome', 'timeFrame': '3, 6, 9, and 12 months', 'description': 'Changes in saliva metabolome measured by untargeted metabolomics'}, {'measure': 'Infant tooth development', 'timeFrame': '3, 6, 9, and 12 months', 'description': 'Infant tooth development during the first year of life'}, {'measure': 'Infant sleep patterns', 'timeFrame': '3, 6, 9, and 12 months', 'description': 'Infant sleep patterns during the first year of life based on the Brief Infant Sleep Questionnaire (BISQ)'}, {'measure': 'Infant motor development', 'timeFrame': '3, 6, 9, and 12 months', 'description': 'Infant motor development as assessed by World Health Organization (WHO) assessment of motor milestones'}, {'measure': 'Mental well-being of infants', 'timeFrame': '9 and 12 months', 'description': 'Infant mental health as assessed by the Copenhagen Infant Mental Health Screening (CIMHS) at 9 and 12 months of age'}], 'primaryOutcomes': [{'measure': 'Infant gut microbiome composition', 'timeFrame': 'Faecal samples collected bi-weekly from birth until 12 months', 'description': 'Changes in gut microbiome measured by DNA/RNA sequencing of longitudinal faecal samples from infants'}], 'secondaryOutcomes': [{'measure': 'Infant gut metabolome', 'timeFrame': 'Faecal samples collected bi-weekly from birth until 12 months', 'description': 'Faecal metabolome as assessed by untargeted metabolomics'}, {'measure': 'Infant bowel habits', 'timeFrame': 'Bi-weekly from birth until 12 months', 'description': 'Changes in bowel habits as measured by stool frequency, stool consistency and stool colour from birth through to 12 months of age'}, {'measure': 'Infant intestinal transit time', 'timeFrame': '9 and 12 months', 'description': 'Intestinal transit time estimated by sweet-corn transit time through the gastrointestinal tract'}, {'measure': 'Infant dietary patterns', 'timeFrame': 'Bi-weekly from birth until 12 months', 'description': 'Changes in dietary patterns recorded using food frequency questionnaires'}, {'measure': 'Infant nutrient intake', 'timeFrame': '6, 9 and 12 months', 'description': 'Assessment of dietary intake by 3-days 24-hour recall'}, {'measure': 'Total faecal bacteria', 'timeFrame': 'Faecal samples collected bi-weekly from birth until 12 months', 'description': 'Changes in total faecal bacteria as measured by quantitative PCR and flow cytometry'}, {'measure': 'Infant body weight', 'timeFrame': '0, 1, 3, 6, 9, and 12 months', 'description': 'Changes in body weight from birth measured in gram (g) or kilogram (kg)'}, {'measure': 'Infant body length', 'timeFrame': '0, 1, 3, 6, 9, and 12 months', 'description': 'Changes in body length measured in centimeters (cm)'}, {'measure': 'Infant growth', 'timeFrame': '0, 1, 3, 6, 9, and 12 months', 'description': 'Infant weight and length will be aggregated to determine infant growth status'}, {'measure': 'Infant head circumference', 'timeFrame': '0, 1, 3, 6, 9, and 12 months', 'description': 'Changes in head circumference measured in centimeters (cm)'}, {'measure': 'Infant fat stores', 'timeFrame': '3, 6, 9, and 12 months', 'description': 'Changes in skin folds (triceps \\& subscapularis) measured with a skinfold caliper'}, {'measure': 'Infant body composition', 'timeFrame': '9 and 12 months', 'description': 'Changes in body composition as measured by bioimpedance'}, {'measure': 'Infant urine metabolome', 'timeFrame': '2 days, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months', 'description': 'Changes in urine metabolome as assessed by untargeted metabolomics'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Microbiome', 'Metabolomics', 'Nutrition', 'Bowel habits'], 'conditions': ['Diet, Healthy', 'Infant Development']}, 'referencesModule': {'references': [{'pmid': '40533209', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThe 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.\n\nThe 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).\n\nThe 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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy population', 'healthyVolunteers': True, 'eligibilityCriteria': "Mothers Inclusion Criteria:\n\n* Age: 18-40 years of age at inclusion\n* Speaking Danish (since all written and oral information will be in Danish)\n* Willing to store their child's biological samples in a small closed container in their own freezer at home\n\nMothers Exclusion Criteria:\n\n* Gestational age more than 34 weeks at time of recruitment\n* Diagnosed with gestational diabetes during this current pregnancy\n* Diagnosed with preeclampsia during this current pregnancy\n* Diagnosed with any severe or chronic diseases\\*\n* Expecting triplets or higher order of multiple pregnancy\n* Concurrent participation in another study\n* Not capable of following the examinations according to the investigator´s instructions\n\nInfants Inclusion Criteria:\n\n\\- Gestational age at birth: 36 weeks or later\n\nInfants Exclusion Criteria:\n\n\\- Severe chronic illness"}, 'identificationModule': {'nctId': 'NCT05491161', 'acronym': 'MOTILITY', 'briefTitle': 'The Motility Mother-Child Cohort', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'The Motility Mother-Child Cohort - Gut Microbes, Diet and Bowel Habits in Early Life', 'orgStudyIdInfo': {'id': 'M241'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Longitudinal study', 'type': 'OTHER', 'description': 'Longitudinal study following infant development from birth to 1 year of age'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1958', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'University of Copenhagen, Department of Nutrition, Exercise and Sports', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'University College Cork', 'class': 'OTHER'}, {'name': 'Technical University of Munich', 'class': 'OTHER'}, {'name': 'Quadram Institute Bioscience', 'class': 'OTHER'}, {'name': 'University of Aarhus', 'class': 'OTHER'}, {'name': 'Technical University of Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Henrik Munch Roager', 'investigatorAffiliation': 'University of Copenhagen'}}}}