Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-26 @ 1:13 AM
Study NCT ID:
NCT04994834
Status:
COMPLETED
Last Update Posted:
2022-07-12
First Post:
2021-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Characterization of the Gastrointestinal Microbiota in Term Newborn Infants After 4 Weeks 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': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-11', 'studyFirstSubmitDate': '2021-06-30', 'studyFirstSubmitQcDate': '2021-08-02', 'lastUpdatePostDateStruct': {'date': '2022-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mothers fecal microbiota', 'timeFrame': 'Baseline', 'description': "Characterization of mother's microbiota from fecal samples will be assessed using sequencing to examine the microbiota for similarities with the infant"}, {'measure': 'Infant Gastrointestinal Problems', 'timeFrame': '42 days', 'description': 'Infant Gastrointestinal Problems will be measured using ROME IV Diagnostic Questionnaires for Pediatric Functional Gastrointestinal Disorders for Neonates and Toddlers: Parent-Report Form for Neonates Section A - Infant Gastrointestinal Problems'}, {'measure': 'Stool frequency and consistency', 'timeFrame': '42 days', 'description': 'Infant stool frequency and consistency will be measured using Amsterdam Stool Chart.'}, {'measure': 'Reflux', 'timeFrame': '42 days', 'description': 'Reflux will be measured using Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R)'}, {'measure': 'Breastmilk microbiome', 'timeFrame': 'Baseline, Day 14, Day 28', 'description': 'Microbiome of the breastmilk to be assessed using sequencing to explore a potential microbiota of the breastmilk'}, {'measure': 'Mothers vaginal microbiota', 'timeFrame': 'Baseline', 'description': "Characterization of mother's vaginal microbiota will be assessed using sequencing to examine the microbiota for similarities with the infant"}], 'primaryOutcomes': [{'measure': 'Recovery of the investigational product in the infant feces', 'timeFrame': '28 days after birth', 'description': 'Presence of the investigational product in infant fecal samples after 4 weeks of supplementation (Visit 4) using PCR'}], 'secondaryOutcomes': [{'measure': 'Total fecal Bifidobacterium in infant fecal samples', 'timeFrame': 'Baseline, Day14, Day 28', 'description': 'Total fecal Bifidobacterium in infant fecal samples after 4 weeks supplementation Quantification of total Bifidobacterium will be determined by PCR.'}, {'measure': 'Characterization of the infant intestinal microbiota after 4 weeks supplementation', 'timeFrame': 'Baseline, Day 14, Day 28', 'description': 'Characterization of the infant intestinal microbiota after 4 weeks supplementation of the investigational product using sequencing'}, {'measure': 'Adverse events (Safety)', 'timeFrame': 'up to 6 weeks', 'description': 'Frequency and severity of adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gut Microbiota']}, 'descriptionModule': {'briefSummary': 'A mono center, open label, pilot study in term newborn infants. The study will investigate the effect of supplementation with probiotics on the presence of total Bifidobacterium in the infant feces.', 'detailedDescription': 'The four weeks intervention starts within 24 hours after birth of the study subject and the investigational product will be given for 28 days, followed by a two weeks follow-up period without any intake of the investigational product.\n\nDuring the entire study period, five visits are scheduled. Visit 2 to Visit 5 are home visits by the study midwife. From Visit 2 and throughout the study period (Visit 2 to Visit 5) the parents will be asked to complete a diary daily.\n\nInfant stool samples will be collected on multiple occasions during the study, as well as maternal breast milk samples, stool and urine samples and samples from vagina. 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': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Months', 'minimumAge': '0 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Infants to be enrolled at birth.\n\nInclusion Criteria for Infants (study subjects)\n\n* Gestational age at birth ≥ 37±0 ≤ weeks 42±0 weeks\n* Birthweight more than 2500 g\n* No exposure to oral or intravenous antibiotics\n* No complications that need medical interventions (e.g. respiratory distress symptoms or infections)\n* Both legal guardians provided voluntary written informed consent on behalf of the infant\n\nPregnant women:\n\n* Women age above 18 years at informed consent\n* Singleton pregnancy\n* Uncomplicated pregnancy\n* No use of medication\n* Aim to give birth vaginally and breastfeed\n* No use of probiotics during the last month before estimated birth and until six weeks postpartum\n* Provided voluntary written informed consent\n\nExclusion criteria for Infants (study subjects)\n\n• Admission to the neonatal intensive care unit (NICU)'}, 'identificationModule': {'nctId': 'NCT04994834', 'briefTitle': 'Characterization of the Gastrointestinal Microbiota in Term Newborn Infants After 4 Weeks Supplementation of Probiotics', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chr Hansen'}, 'officialTitle': 'Characterization of the Gastrointestinal Microbiota in Term Newborn Infants After 4 Weeks Supplementation of Probiotics - an Open Label Pilot Study', 'orgStudyIdInfo': {'id': 'HND-IN-037'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Probiotics', 'interventionNames': ['Dietary Supplement: Probiotics']}], 'interventions': [{'name': 'Probiotics', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Once a day daily intake of probiotics for at least 28 consecutive starting within 24 hours after 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, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Gynecology and Obstetrics, Aarhus University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'To share IPD not decided yet'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chr Hansen', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}