Ignite Creation Date:
2025-12-26 @ 10:43 PM
Ignite Modification Date:
2025-12-26 @ 10:43 PM
Study NCT ID:
NCT04721912
Status:
COMPLETED
Last Update Posted:
2025-01-14
First Post:
2020-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Group B Streptococcus Response After Probiotic Exposure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D013290', 'term': 'Streptococcal Infections'}], 'ancestors': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hsc-familyplanningresearch@salud.unm.edu', 'phone': '505-205-4118', 'title': 'Katrina Nardini, CNM, WHNP-BC, MPH', 'organization': 'University of New Mexico'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Participants and researchers were not masked to group assignment which may have led to unintended biases in responses and interpretation of questionnaires. Several IP samples were missed. The COVID-19 pandemic limited recruitment and may have prevented recruitment of those who would otherwise have participated. There were significant problems with laboratory processing of IP GBS swabs, resulting in 23 laboratory samples not being analyzed.'}}, 'adverseEventsModule': {'timeFrame': 'T1 (baseline; 36.0-37.6 weeks) through T5 (6 week postpartum visit; up to 12 weeks and 6 days from baseline)', 'description': 'We did not find any reports of adverse events in our study participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Standard of Care', 'description': 'Subjects in the control group will not receive any Probiotic capsules and will be advised to continue their routine prenatal self-care.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Probiotic Dietary Supplement', 'description': 'Participants in the intervention group will begin taking oral study Probiotic capsules once daily from time of enrollment/randomization at ≥ 36 weeks gestation until the time of birth. The research staff member will sequentially distribute the pre-labeled bottles of study capsules to the intervention group, one bottle of 30 Florajen Digestion probiotic capsules to women in the intervention group at the time of randomization.\n\nProbiotic dietary supplement: GBS positive patients, at ≥ 36 weeks gestation, will begin taking oral Florajen Digestion probiotic capsules once daily from time of enrollment/randomization at ≥ 36 weeks gestation until the time of birth.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'GBS Culture Result (Positive Versus Negative)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care', 'description': 'Subjects in the control group will not receive any Probiotic capsules and will be advised to continue their routine prenatal self-care.'}, {'id': 'OG001', 'title': 'Probiotic Dietary Supplement', 'description': 'Participants in the intervention group will begin taking oral study Probiotic capsules once daily from time of enrollment/randomization at ≥ 36 weeks gestation until the time of birth. The research staff member will sequentially distribute the pre-labeled bottles of study capsules to the intervention group, one bottle of 30 Florajen Digestion probiotic capsules to women in the intervention group at the time of randomization.\n\nProbiotic dietary supplement: GBS positive patients, at ≥ 36 weeks gestation, will begin taking oral Florajen Digestion probiotic capsules once daily from time of enrollment/randomization at ≥ 36 weeks gestation until the time of birth.'}], 'classes': [{'categories': [{'title': 'Negative Qualitative GBS Colonization', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Positive Qualitative GBS Colonization', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'T2 (admission to Labor and Delivery; 36 - 42 weeks gestational age)', 'description': 'Qualitative GBS colonization (positive versus negative)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Probiotic Pill Count to Measure Intervention Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care', 'description': 'Subjects in the control group will not receive any Probiotic capsules and will be advised to continue their routine prenatal self-care.'}, {'id': 'OG001', 'title': 'Probiotic Dietary Supplement', 'description': 'Participants in the intervention group will begin taking oral study Probiotic capsules once daily from time of enrollment/randomization at ≥ 36 weeks gestation until the time of birth. The research staff member will sequentially distribute the pre-labeled bottles of study capsules to the intervention group, one bottle of 30 Florajen Digestion probiotic capsules to women in the intervention group at the time of randomization.\n\nProbiotic dietary supplement: GBS positive patients, at ≥ 36 weeks gestation, will begin taking oral Florajen Digestion probiotic capsules once daily from time of enrollment/randomization at ≥ 36 weeks gestation until the time of birth.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'spread': '7.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'T3 (Postpartum day 0-14, up to 8 weeks from Baseline)', 'description': 'Intervention adherence by pill count for probiotic participants', 'unitOfMeasure': 'Average Florajen Digestion Pills', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Standard of Care participants did not receive probiotics and thus did not possess probiotic capsules to count and thus this analysis does not apply to this group.'}, {'type': 'SECONDARY', 'title': 'Antepartum Gastrointestinal Symptom Assessment (AP-GI-SA) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care', 'description': 'Subjects in the control group will not receive any Probiotic capsules and will be advised to continue their routine prenatal self-care.'}, {'id': 'OG001', 'title': 'Probiotic Dietary Supplement', 'description': 'Participants in the intervention group will begin taking oral study Probiotic capsules once daily from time of enrollment/randomization at ≥ 36 weeks gestation until the time of birth. The research staff member will sequentially distribute the pre-labeled bottles of study capsules to the intervention group, one bottle of 30 Florajen Digestion probiotic capsules to women in the intervention group at the time of randomization.\n\nProbiotic dietary supplement: GBS positive patients, at ≥ 36 weeks gestation, will begin taking oral Florajen Digestion probiotic capsules once daily from time of enrollment/randomization at ≥ 36 weeks gestation until the time of birth.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '15.6', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '15.0', 'spread': '3.3', 'groupId': 'OG001'}]}]}, {'title': 'Post-birth', 'categories': [{'measurements': [{'value': '14.5', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '13.5', 'spread': '4.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline T1 (36-37.6 weeks gestational age) and T3 (postpartum day 0-14; up to 8 weeks from baseline)', 'description': 'Maternal gastrointestinal (GI) symptoms based on AP-GI-SA score: lowest score 10, highest score 50 (high score means more symptoms = worse outcome)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Report Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care', 'description': 'Subjects in the control group will not receive any Probiotic capsules and will be advised to continue their routine prenatal self-care.'}, {'id': 'OG001', 'title': 'Probiotic Dietary Supplement', 'description': 'Participants in the intervention group will begin taking oral study Probiotic capsules once daily from time of enrollment/randomization at ≥ 36 weeks gestation until the time of birth. The research staff member will sequentially distribute the pre-labeled bottles of study capsules to the intervention group, one bottle of 30 Florajen Digestion probiotic capsules to women in the intervention group at the time of randomization.\n\nProbiotic dietary supplement: GBS positive patients, at ≥ 36 weeks gestation, will begin taking oral Florajen Digestion probiotic capsules once daily from time of enrollment/randomization at ≥ 36 weeks gestation until the time of birth.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'T1 (baseline; 36.0-37.6 weeks gestational age) through T5 (6 weeks postpartum visit; up to 12 weeks and 6 days from baseline)', 'description': 'Maternal adverse events by organ system and severity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Report Adverse Events in Their Infant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care', 'description': 'Subjects in the control group will not receive any Probiotic capsules and will be advised to continue their routine prenatal self-care.'}, {'id': 'OG001', 'title': 'Probiotic Dietary Supplement', 'description': 'Participants in the intervention group will begin taking oral study Probiotic capsules once daily from time of enrollment/randomization at ≥ 36 weeks gestation until the time of birth. The research staff member will sequentially distribute the pre-labeled bottles of study capsules to the intervention group, one bottle of 30 Florajen Digestion probiotic capsules to women in the intervention group at the time of randomization.\n\nProbiotic dietary supplement: GBS positive patients, at ≥ 36 weeks gestation, will begin taking oral Florajen Digestion probiotic capsules once daily from time of enrollment/randomization at ≥ 36 weeks gestation until the time of birth.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'T2 (admission to Labor and Delivery; 36 - 42 weeks gestational age) through T5 (6 weeks postpartum visit; up to 12 weeks and 6 days from baseline)', 'description': 'Infant adverse events by organ system and severity', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard of Care', 'description': 'Subjects in the control group will not receive any Probiotic capsules and will be advised to continue their routine prenatal self-care.'}, {'id': 'FG001', 'title': 'Probiotic Dietary Supplement', 'description': 'Participants in the intervention group will begin taking oral study Probiotic capsules once daily from time of enrollment/randomization at ≥ 36 weeks gestation until the time of birth. The research staff member will sequentially distribute the pre-labeled bottles of study capsules to the intervention group, one bottle of 30 Florajen Digestion probiotic capsules to women in the intervention group at the time of randomization.\n\nProbiotic dietary supplement: GBS positive patients, at ≥ 36 weeks gestation, will begin taking oral Florajen Digestion probiotic capsules once daily from time of enrollment/randomization at ≥ 36 weeks gestation until the time of birth.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard of Care', 'description': 'Subjects in the control group will not receive any Probiotic capsules and will be advised to continue their routine prenatal self-care.'}, {'id': 'BG001', 'title': 'Probiotic Dietary Supplement', 'description': 'Participants in the intervention group will begin taking oral study Probiotic capsules once daily from time of enrollment/randomization at ≥ 36 weeks gestation until the time of birth. The research staff member will sequentially distribute the pre-labeled bottles of study capsules to the intervention group, one bottle of 30 Florajen Digestion probiotic capsules to women in the intervention group at the time of randomization.\n\nProbiotic dietary supplement: GBS positive patients, at ≥ 36 weeks gestation, will begin taking oral Florajen Digestion probiotic capsules once daily from time of enrollment/randomization at ≥ 36 weeks gestation until the time of birth.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '28.8788', 'spread': '5.40693', 'groupId': 'BG000'}, {'value': '29.9688', 'spread': '6.36261', 'groupId': 'BG001'}, {'value': '29.42', 'spread': '5.88', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Although 68 participants were randomized, 3 withdrew prior to obtaining age data and thus were not included in analysis.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'Race', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Relationship Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Single/widowed', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Partnered/married', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Living Arrangements', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Lives with others', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'Lives alone', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education Level', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'categories': [{'title': 'HS/GED/some college', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'College', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Graduate Degree', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Socio-economic status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'categories': [{'title': '<$40,000', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': '$40,000-99,999', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': '>$100,000', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Prefer not to answer', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Parity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Nulliparous', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Multiparous', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-02', 'size': 292249, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-08-29T12:05', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Healthy pregnant participants will be randomly assigned to one of two groups (Probiotic vs No Probiotic (standard of care)). The Probiotic group will take one capsule daily and have the same study measures at the same times.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-09', 'studyFirstSubmitDate': '2020-12-07', 'resultsFirstSubmitDate': '2024-09-05', 'studyFirstSubmitQcDate': '2021-01-19', 'lastUpdatePostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-09', 'studyFirstPostDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'GBS Culture Result (Positive Versus Negative)', 'timeFrame': 'T2 (admission to Labor and Delivery; 36 - 42 weeks gestational age)', 'description': 'Qualitative GBS colonization (positive versus negative)'}], 'secondaryOutcomes': [{'measure': 'Probiotic Pill Count to Measure Intervention Adherence', 'timeFrame': 'T3 (Postpartum day 0-14, up to 8 weeks from Baseline)', 'description': 'Intervention adherence by pill count for probiotic participants'}, {'measure': 'Antepartum Gastrointestinal Symptom Assessment (AP-GI-SA) Score', 'timeFrame': 'Baseline T1 (36-37.6 weeks gestational age) and T3 (postpartum day 0-14; up to 8 weeks from baseline)', 'description': 'Maternal gastrointestinal (GI) symptoms based on AP-GI-SA score: lowest score 10, highest score 50 (high score means more symptoms = worse outcome)'}, {'measure': 'Number of Participants Who Report Adverse Events', 'timeFrame': 'T1 (baseline; 36.0-37.6 weeks gestational age) through T5 (6 weeks postpartum visit; up to 12 weeks and 6 days from baseline)', 'description': 'Maternal adverse events by organ system and severity.'}, {'measure': 'Number of Participants Who Report Adverse Events in Their Infant', 'timeFrame': 'T2 (admission to Labor and Delivery; 36 - 42 weeks gestational age) through T5 (6 weeks postpartum visit; up to 12 weeks and 6 days from baseline)', 'description': 'Infant adverse events by organ system and severity'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pregnancy', 'Group B Strep positive'], 'conditions': ['Group B Strep Infection']}, 'referencesModule': {'references': [{'pmid': '40442923', 'type': 'DERIVED', 'citation': 'Nardini K, Hanson L, Borders N, Singh M, Shields A, Trujillo VY, Lawton R, Malloy E. Open-Label Randomized Controlled Trial and Feasibility Study of an Oral Probiotic Intervention to Reduce Group B Streptococcus Colonization in Pregnant People by the Time of Birth. J Midwifery Womens Health. 2025 May-Jun;70(3):460-467. doi: 10.1111/jmwh.13765. Epub 2025 May 29.'}]}, 'descriptionModule': {'briefSummary': 'This is an open-label randomized control trial and feasibility study designed to determine the feasibility of a larger RCT in our setting that would examine prenatal probiotic use in Group B Strep (GBS) positive pregnant women at term. Investigators hope to address the question of whether prenatal oral probiotic use, taken by healthy low risk GBS positive women from approximately 37 weeks gestation until the time of birth, will reduce the number of women who test positive for GBS at the time of admission to Labor and Delivery (L\\&D).', 'detailedDescription': 'This is an open-label randomized control trial and feasibility study designed to determine the feasibility of a larger RCT in our setting that would examine prenatal probiotic use in Group B Strep (GBS) positive pregnant women at term. We hope to address the question of whether prenatal oral probiotic use, taken by healthy low risk GBS positive women from approximately 37 weeks gestation until the time of birth, will reduce the number of women who test positive for GBS at the time of admission to Labor and Delivery (L\\&D). In this study we aim to determine whether such a study is acceptable in our population, whether any adverse events are identified, and what barriers or confounding variables might exist to probiotic use at term. We will also look at whether probiotic use had any reported effect on maternal gastrointestinal (GI) symptoms.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Healthy adult (≥ 18 years of age) pregnant women who are 36 - 37 6/7 weeks gestation at enrollment \\[calculated from the first day of Last Normal Menstrual Period (LNMP) and/or ultrasound (US)\\]\n\nGroup B Streptococcus Positive at 36 weeks gestation with:\n\n* No obstetric complication requiring delivery prior to 39 weeks (hypertensive disorder diagnosed prior to enrollment, gestational diabetes, multiple gestation)\n* No fetal complication (e.g., birth defect, intrauterine growth restriction)\n* No medical complication (e.g., chronic hypertension, preexisting diabetes mellitus)\n* Who do not currently ingest an over the counter probiotic supplement (not including yogurt)\n* Who can both speak and read English or Spanish\n* Pregnant women who regularly attend UNM prenatal clinics for their prenatal care ("regularly attend" will be defined as starting prenatal care prior to 20 weeks gestation and missing no more than one prenatal appointment during this pregnancy)\n* No hypersensitivity reaction to β-lactam antibiotics\n\nExclusion Criteria:\n\n* Those less than 18 years of age\n* Non-pregnant women\n* Later in pregnancy than 38 weeks gestation at enrollment \\[per LNMP and/or US\\]\n* Those with an obstetric, fetal or medical complication of pregnancy\n* Group B Streptococcus negative at 36 weeks gestation. Those ineligible for testing at 36 weeks gestation (history of GBS bacteriuria during the current pregnancy or have previously given birth to a GBS affected child.) We will not exclude those with bacteriuria other than GBS, and we will not exclude women who have taken an antibiotic during pregnancy, but we will track this as it is addressed in the Questionnaire for Women.\n* Women who are currently ingesting an over the counter probiotic supplement (except for yogurt)\n* Women who do not have electricity in the home.\n* Women who are planning an elective repeat cesarean birth\n* Women who do not speak and read English or Spanish\n* Women with a history of missing one or more scheduled prenatal visit during this pregnancy\n* Hypersensitivity reaction to β-lactam antibiotics'}, 'identificationModule': {'nctId': 'NCT04721912', 'acronym': 'GRAPE', 'briefTitle': 'Group B Streptococcus Response After Probiotic Exposure', 'organization': {'class': 'OTHER', 'fullName': 'University of New Mexico'}, 'officialTitle': 'Open-label Randomized Control Trial and Feasibility Study of Florjajen Digestion Probiotics to Reduce GBS Colonization in Pregnant Women by the Time of Birth.', 'orgStudyIdInfo': {'id': '20-396'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'Subjects in the control group will not receive any Probiotic capsules and will be advised to continue their routine prenatal self-care.'}, {'type': 'EXPERIMENTAL', 'label': 'Probiotic Dietary Supplement', 'description': 'Participants in the intervention group will begin taking oral study Probiotic capsules once daily from time of enrollment/randomization at ≥ 36 weeks gestation until the time of birth. The research staff member will sequentially distribute the pre-labeled bottles of study capsules to the intervention group, one bottle of 30 Florajen Digestion probiotic capsules to women in the intervention group at the time of randomization.', 'interventionNames': ['Drug: Probiotic dietary supplement']}], 'interventions': [{'name': 'Probiotic dietary supplement', 'type': 'DRUG', 'otherNames': ['Florajen Digestion™'], 'description': 'GBS positive patients, at ≥ 36 weeks gestation, will begin taking oral Florajen Digestion probiotic capsules once daily from time of enrollment/randomization at ≥ 36 weeks gestation until the time of birth.', 'armGroupLabels': ['Probiotic Dietary Supplement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87112', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico Hospital', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}], 'overallOfficials': [{'name': 'Katrina Nardini', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of New Mexico'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of New Mexico', 'class': 'OTHER'}, 'collaborators': [{'name': 'Marquette University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator, CNM, WHNP-BC, MPH', 'investigatorFullName': 'Katrina A. Nardini', 'investigatorAffiliation': 'University of New Mexico'}}}}