Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 11:48 PM
Study NCT ID:
NCT06974994
Status:
RECRUITING
Last Update Posted:
2025-05-16
First Post:
2025-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Resilience to Antibiotic-induced Obesogenic Microbiota: Discovering Mechanism of Microbiota Modulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003141', 'term': 'Communicable Diseases'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, placebo-controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 125}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-07', 'studyFirstSubmitDate': '2025-04-27', 'studyFirstSubmitQcDate': '2025-05-07', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BMI at 24 months of age', 'timeFrame': 'From enrollment to 24 months of age', 'description': "Child's body mass index (BMI) at the age of 24 months"}], 'secondaryOutcomes': [{'measure': 'Height', 'timeFrame': 'From enrollment to 24 months of age', 'description': "Child's height at the age of 6, 12, 18, and 24 months"}, {'measure': 'Weight', 'timeFrame': 'From enrollment to 24 months of age', 'description': "Child's weight at the age of 6, 12, 18, and 24 months"}, {'measure': 'Growth velocity', 'timeFrame': 'From enrollment to 3 months of age', 'description': "Child's growth velocity at 2-3 months of age"}, {'measure': "Child's microbiome", 'timeFrame': 'From enrollment to 24 months of age', 'description': "The function and composition of the child's gut, nasal, and mouth microbiome at the age of 2, 6, 12, 18, and 24 months"}, {'measure': "Mother's microbiome", 'timeFrame': 'From enrollment to 6 months after giving birth', 'description': "The function and composition of the mother's gut, nasal, and mouth microbiome when the child is 2 and 6 months of age"}, {'measure': 'Breast milk microbiome', 'timeFrame': 'From enrollment to 6 months of age', 'description': "The composition of breast milk's microbiome when the child is 2 and 6 months of age"}, {'measure': 'Hormonal levels', 'timeFrame': 'From enrollment to 6 months of age', 'description': "Child's hormonal levels (testosterone, sex hormone-binding globulin, luteinizing hormone and follicle-stimulating hormone) at birth and at the age of 2 and 6 months"}, {'measure': 'Inflammatory markers', 'timeFrame': 'From enrollment to 6 months of age', 'description': 'Systemic inflammation markers (cytokines, C-reactive protein, soluble urokinase-type plasminogen activator receptor and haptoglobulin) at birth and at the age of 2 and 6 months'}, {'measure': 'Respiratory tract infections', 'timeFrame': 'From enrollment to 24 months of age', 'description': 'Respiratory tract infections by the age of 24 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['antibiotics', 'human milk oligosaccharides', 'probiotics', 'newborn', 'microbiome', 'microbiota', 'obesity', 'infectious diseases'], 'conditions': ['Healthy Newborn Infants']}, 'descriptionModule': {'briefSummary': 'The aim is to study whether the microbiota of children who are exposed to antibiotics at birth could be modified by synbiotic supplement and thereby reduce the risk of obesity, chronic diseases and respiratory tract infections. A total of 125 mother-child pairs will be recruited in this randomized, double-blind, placebo-controlled study. Infants are randomized to receive either a synbiotic supplement or a placebo for 2 months, after which their growth and morbidity will be monitored at the research clinic for 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Hours', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPregnant women (n=125) and their newborn children who receive antibiotic treatment at delivery.\n\nExclusion Criteria:\n\n* Chorioamnionitis\n* Pre-eclampsia and hepatogestosis\n* Suspected malformation or serious condition of the foetus and neonates\n* Serious infection or other conditions not permitting breast milk feeding'}, 'identificationModule': {'nctId': 'NCT06974994', 'acronym': 'ReCoverHealth', 'briefTitle': 'Resilience to Antibiotic-induced Obesogenic Microbiota: Discovering Mechanism of Microbiota Modulation', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Turku University Hospital'}, 'officialTitle': 'Resilience to Antibiotic-induced Obesogenic Microbiota Vertically Transferred to the Neonatal Gut: Discovering Mechanism of Microbiota Modulation', 'orgStudyIdInfo': {'id': 'T1927_2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Synbiotic', 'description': 'Bifidobacterium bifidum and human milk oligosaccharides (HMOs)', 'interventionNames': ['Dietary Supplement: Synbiotic Supplement']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Synbiotic Supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Bifidobacterium bifidum and human milk oligosaccharides (HMOs)', 'armGroupLabels': ['Synbiotic']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Maltodextrin', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20780', 'city': 'Turku', 'state': 'Valitse Maakunta.', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Paula Tähtinen, MD, PhD', 'role': 'CONTACT', 'email': 'paula.tahtinen@utu.fi', 'phone': '+358-2-3130746'}, {'role': 'CONTACT', 'email': 'paula.tahtinen@utu.fi'}, {'name': 'Erika Isolauri, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Paula Tähtinen, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tuuli Vuorisalo, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Paediatrics and Adolescent Medicine, Turku University Hospital and University of Turku', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'centralContacts': [{'name': 'Paula Tähtinen, MD, PhD', 'role': 'CONTACT', 'email': 'paula.tahtinen@utu.fi', 'phone': '+358-2-3130746'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', 'description': 'IPD may be shared for research purposes upon special request to the PI'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Lallemand Health Solutions', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Paediatrics', 'investigatorFullName': 'Erika Isolauri', 'investigatorAffiliation': 'Turku University Hospital'}}}}