Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-30 @ 5:27 PM
Study NCT ID:
NCT05156333
Status:
SUSPENDED
Last Update Posted:
2022-11-07
First Post:
2021-10-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Probiotics and GBS Colonization in Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071074', 'term': 'Neonatal Sepsis'}], 'ancestors': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'The randomization (1: 1) will take place in each center, using the same allocation sequence, in blocks of 4, with the indication of the treatment code inserted in a white, closed envelope. The code will correspond to the number written on the packages to be administered and the list of codes containing the definition of the treatments, will be kept in a sealed envelope, by a collaborator of the PI (Head Nurse), and opened upon completion of the study or at the time of need, in case maternal-fetal or neonatal serious adverse event.\n\nNo member of the research team knows which treatment the patients receive because both the active and the placebo are packaged identically and are contained in identical white boxes. Only the randomization numbers distinguish them.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicenter, prospective, randomized, placebo-controlled, double-blind, parallel-group study aimed at underestimating the feasibility and effect of the use of probiotic starting from week 30 on vaginal / rectal colonization of GBS in women at low obstetric risk.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 402}}, 'statusModule': {'whyStopped': 'Uneffective', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2020-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-02', 'studyFirstSubmitDate': '2021-10-05', 'studyFirstSubmitQcDate': '2021-12-13', 'lastUpdatePostDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'PROM', 'timeFrame': 'pre-labor', 'description': 'Prelabor rupture of membranes evaluated according to clinical signs or fibronectin test'}, {'measure': 'Pathologic APGAR score', 'timeFrame': 'at delivery', 'description': "The Apgar score is a measure of a baby's condition after birth. It guides midwives, doctors and nurses as to whether a baby needs immediate treatment or monitoring. It is used to check a newborn baby born at 1 minute and 5 minutes after their birth. It is named after Dr Virginia Apgar who developed the score.\n\nThe Apgar score goes from 0 to 10 and it is classified as pathologic when is \\</= 7"}, {'measure': 'Need for neonatal antibiotics', 'timeFrame': 'within the first 48 hours after birth', 'description': 'Rate of neonates requiring antibiotics within the first 48h of life'}, {'measure': 'Neonatal sepsis', 'timeFrame': 'within the first week after birth', 'description': 'Rate of neonates developing a sepsis'}], 'primaryOutcomes': [{'measure': 'GBS Rectovaginal colonization', 'timeFrame': 'at 35-37 weeks', 'description': 'Rate of colonized GBS pregnant (carriers) at the time of antepartum screening (35-37 \\^ week).'}], 'secondaryOutcomes': [{'measure': 'Intrapartum antibiotics profilaxisi', 'timeFrame': 'during labor', 'description': 'Rata of women requiring antibiotic profilaxis intrapartum'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Probiotics', 'Pregnancy', 'GBS colonization'], 'conditions': ['GBS Rectovaginal Colonization', 'Neonatal Sepsis']}, 'descriptionModule': {'briefSummary': 'Multicentric, randomized, placebo-controlled, double-blind, parallel group study aimed at evaluating the feasibility and effect of the use of probiotic starting from the 30th week, on vaginal / rectal colonization of GBS in women at low obstetric risk.', 'detailedDescription': 'Multicenter, randomized, placebo-controlled, double-blind, parallel group study aimed at evaluating the feasibility and effect of the use of probiotic starting from the 30th week, on vaginal / rectal colonization of GBS in women at low obstetric risk.\n\nThe study includes low obstetric risk pregnant women within the 33rd week of gestation, with vaginal delivery expected. It excludes women who during pregnancy had a positive urine culture for GBS, women with a previous newborn suffering from early sepsis, use of antibiotics in the month prior to enrollment, women unable to understand the study and sign informed consent.\n\nIntervention Daily oral administration of two capsules of the Giellepi Spa class IIa medical device "Respecta" or placebo, to be taken with a glass of water preferably between meals, starting from the 30th week of pregnancy until the 37th week after having vagino-rectal swab screening performed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'pregnant women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* low obstetric risk pregnant women by the 33rd week of gestation,\n* vaginal delivery expected.\n\nExclusion Criteria:\n\n* positive urine culture for GBS,\n* previous newborn suffering from early sepsis,\n* use of antibiotics in the month prior to enrollment,\n* women unable to understand the study and sign informed consent.'}, 'identificationModule': {'nctId': 'NCT05156333', 'briefTitle': 'Probiotics and GBS Colonization in Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'University of Modena and Reggio Emilia'}, 'officialTitle': 'Probiotics in Pregnancy and Rectovaginal Group B Streptococcus (GBS) Colonization', 'orgStudyIdInfo': {'id': 'AOU 0025949/19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Daily oral administration of 1 capusle of placebo, composed of: hydroxypropylmethylcellulose; Anti-caking agent: Magnesium salts of fatty acids, Dioxide of silicon; Dye: E171.', 'interventionNames': ['Dietary Supplement: Respecta']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Probiotic', 'description': 'Daily oral administration of 1 capsule of mixture of probiotics and milk glycoproteins with prebiotic action); Cornstarch; Anti-caking agents: Vegetable magnesium stearate, Silicon dioxide; Capsule orally administered: Hydroxypropylmethylcellulose (coloring: E171).', 'interventionNames': ['Dietary Supplement: Respecta']}], 'interventions': [{'name': 'Respecta', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Probiotic'], 'description': 'Respecta® complex (mixture of probiotics and milk glycoproteins with prebiotic action); Cornstarch; Anti-caking agents: Vegetable magnesium stearate, Silicon dioxide; Capsule orally administered: Hydroxypropylmethylcellulose (coloring: E171).\n\nDaily oral administration of two capsules of the Giellepi Spa class IIa medical device "Respecta" or placebo, to be taken with a glass of water preferably between meals, starting from the 30th week of pregnancy until the 37th week after having vagino-rectal swab screening performed.', 'armGroupLabels': ['Placebo', 'Probiotic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20154', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'Ospedale dei Bambini "Vittore Buzzi"', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '42123', 'city': 'Reggio Emilia', 'state': 'RE', 'country': 'Italy', 'facility': 'Arcispedale Santa Maria Nuova Reggio Emilia', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}, {'zip': '41124', 'city': 'Modena', 'country': 'Italy', 'facility': 'University Hospital of Modena', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Modena and Reggio Emilia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Daniela Menichini', 'class': 'UNKNOWN'}, {'name': 'Maria Longo', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the Obstetrics and Gynecolocy department', 'investigatorFullName': 'Prof. Fabio Facchinetti', 'investigatorAffiliation': 'University of Modena and Reggio Emilia'}}}}