Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT04987593
Status:
COMPLETED
Last Update Posted:
2022-07-12
First Post:
2021-06-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Characterisation of the Gut Microbiota in Term Infants After Maternal Supplementation of Probiotics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-11', 'studyFirstSubmitDate': '2021-06-29', 'studyFirstSubmitQcDate': '2021-08-02', 'lastUpdatePostDateStruct': {'date': '2022-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Infant gastrointestinal problems', 'timeFrame': '28 days', 'description': 'Infants gastrointestinal problems will be assessed using the Parent-Report Form for Neonates Section A - Infant Gastrointestinal Problems (ROME IV)'}, {'measure': 'Infant stool frequency and consistency', 'timeFrame': '28 days', 'description': 'Infants stool frequency and consistency will be assessed using Amsterdam Stool Chart'}, {'measure': 'Infant Reflux', 'timeFrame': '28 days', 'description': 'Reflux will be assessed using the Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R)'}, {'measure': 'Adverse events', 'timeFrame': '12 weeks', 'description': 'Any adverse events experienced by either mother or infant will be recorded during the entire study period'}], 'primaryOutcomes': [{'measure': 'Recovery of study product in infant feces', 'timeFrame': '28 days after birth', 'description': 'Presence of at least one of the probiotic strains in infant feces using PCR'}], 'secondaryOutcomes': [{'measure': 'Recovery of study product in maternal feces', 'timeFrame': '28 days', 'description': 'Presence of at least one of the probiotic strains in maternal feces using PCR'}, {'measure': 'Quantification of the microbiota in breastmilk', 'timeFrame': '28 days after birth', 'description': 'Characterization of breastmilk microbiota by and recovery of probiotic strains using PCR'}, {'measure': 'Quantification of the maternal vaginal microbiota', 'timeFrame': '28 days', 'description': 'Characterization of the vaginal microbiota and recovery of probiotic strains using PCR'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infant Development', 'Gut Microbiome']}, 'descriptionModule': {'briefSummary': 'A monocenter, open label pilot study in pregnant women and their offspring with at least four weeks prenatal and four weeks postnatal maternal intervention with a study product consisting of four different food constituents.\n\nThe study will investigate the effect of maternal supplementation with the food constituents on the recovery of the constituents in the maternal and infant feces, the microbiota in both mother and infant and potential transmission routes from mother to infant.', 'detailedDescription': 'Pregnant women will be recruited at the ordinary midwife visit in gestational week 28. The intervention will begin in gestational week 33+0 to ensure at least four weeks prenatal intervention before expected birth.\n\nThe study will be conducted in four phases. First phase is the run-in phase. The second phase is the prenatal intervention period from gestational week 33+0 until birth. Third phase is the postnatal intervention period, from birth until four weeks postnatal. The last phase is a two weeks follow-up period without any intake of the investigational product.\n\nInfant stool samples, as well as maternal breast milk samples, stool and urine samples and samples from vagina will be collected on multiple occasions during the study. In addition, sample from placenta, umbilical cord, umbilical cord blood and amnion fluid will be collected. Mothers will be asked to complete electronic questionnaires daily during the course of the study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\nPregnant women:\n\n1. Enrolled at Aarhus University Hospital\n2. Singleton pregnancy\n3. Age above 18 years at informed consent\n4. Aim to give birth vaginally\n5. Aim to breastfeed\n6. No use of probiotics (contained in dietary supplements/ food) after written consent.\n\nInfants:\n\n1\\. Gestational age between 37-42 weeks\n\nExclusion Criteria:\n\nPregnant women • Use of immunosuppressant drugs.\n\nInfants:\n\n• None'}, 'identificationModule': {'nctId': 'NCT04987593', 'briefTitle': 'Characterisation of the Gut Microbiota in Term Infants After Maternal Supplementation of Probiotics', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chr Hansen'}, 'officialTitle': 'Characterisation of the Gut Microbiota in Term Infants After Maternal Prenatal and Postnatal Supplementation of Probiotics - an Open Label Pilot Study', 'orgStudyIdInfo': {'id': 'HND-IN-039'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Four probiotic strains to be consumed once daily', 'interventionNames': ['Dietary Supplement: Probiotics']}], 'interventions': [{'name': 'Probiotics', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Once a day daily intake of probiotics, at least for 28 consecutive days before giving birth and for at least 28 consecutive days after giving birth', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Department of Gynaecology and Obstetrics', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Lars Henning Pedersen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Gynecology and Obstetrics, Aarhus University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No IPD plan yet'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chr Hansen', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}