Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-27 @ 9:00 PM
Study NCT ID:
NCT05703659
Status:
TERMINATED
Last Update Posted:
2025-08-01
First Post:
2023-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Baby 2 Baby Beneficial Bacteria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "Primary Purpose of this study is epidemiological, and to determine if probiotic species can transmit between infants whose microbiomes are still developing.\n\nMothers and infant dyads will be enrolled and attend 5 weekly lactation support group sessions. After the first session, infants will be randomized to receive 1 of 2 probiotics. Both probiotics are marketed in the US as dietary supplements for infants. At the first support group session and at the final session, infant fecal samples and mother's milk samples will be collected and tested for detectable levels of both probiotics to determine if horizontal transmission of the probiotic species occurred in the setting of a lactation support group."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'Unable to recruit a sufficient number of women in one month to start the lactation support groups.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-29', 'studyFirstSubmitDate': '2023-01-19', 'studyFirstSubmitQcDate': '2023-01-19', 'lastUpdatePostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Transmission of probiotics to non-supplemented infants', 'timeFrame': '4 weeks', 'description': 'Percentage of infants with detectable levels of B. infantis who were not given a B. infantis probiotic and were not colonized by B. infantis at baseline OR percentage of infants with detectable levels of L. reuteri who were not given an L. reuteri probiotic and were not colonized by L. reuteri at baseline.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transmission', 'Beneficial bacteria', 'Probiotic', 'B. longum subsp. infantis', 'L. reuteri', 'breastfed infants'], 'conditions': ['Transmission']}, 'descriptionModule': {'briefSummary': 'The investigators will recruit mother-infant dyads to attend weekly lactation support groups and randomize infants to receive either an HMO consuming or non-HMO consuming probiotic. The investigators will collect infant stool before and after support group attendance. The investigators will use qPCR and metagenomic sequencing to test if the study probiotics or other bacteria transmit between infants. The investigators anticipate HMO consuming bacteria will and non-HMO consuming bacteria will not transmit between infants.', 'detailedDescription': 'The investigators will recruit mother-infant dyads to attend weekly lactation support groups for five weeks and randomize infants to receive either an HMO consuming (B. longum subsp. infantis) or non-HMO consuming (L. reuteri) probiotic. The investigators will collect a baseline infant stool sample and maternal milk sample before attendance at the first lactation support group meeting. At the first support group meeting, mothers will be provided with the open label probiotic their infant was randomized to receive, and will give the probiotic daily for the next 28 days. The investigators will collect a second infant stool sample and a second milk sample at the final lactation support group meeting. The investigators will use qPCR and metagenomic sequencing to test if the study probiotics or other bacteria transmit from the infants who received a specific species to the infants who did not receive that species. We will also test to see if the probiotic given to infants is detectable in milk samples. The investigators anticipate HMO consuming bacteria will and non-HMO consuming bacteria will not transmit between infants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '62 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'NOTE: Age limits listed are for mothers. For infants, age limits are a minimum of 1 day and a maximum of 1 month\n\nInclusion Criteria:\n\n* Healthy singleton pregnancy, term delivery (\\>= 36 weeks corrected gestational age)\n* Maternal intent to exclusively breastfeed for the first six months of infant life (intent to breastfeed for six months correlates with longer duration of breastfeeding, this increases the chance that mothers will still be breastfeeding at the end of the study)\n* Maternal vaccination against COVID19 (2 doses Pfizer or Moderna and within 6 months of second dose or 2 doses Pfizer or Moderna and booster.) COVID vaccination is required for maternal participation as this is a study meant to enable transmission of beneficial bacteria species between infants, and infants are too young to be vaccinated.\n\nExclusion Criteria:\n\n* Maternal drug abuse\n* Infant congenital abnormalities\n* Infant age greater than 1 month at first lactation support group meeting (younger infants will have less developed microbiomes, increasing the chance of successful transmission of bacteria)\n* Intent to provide a non-study probiotics to the infant\n* Known immunocompromised status of the infant.'}, 'identificationModule': {'nctId': 'NCT05703659', 'briefTitle': 'Baby 2 Baby Beneficial Bacteria', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'B2BBB: Baby 2 Baby Beneficial Bacteria', 'orgStudyIdInfo': {'id': 'IRB202200652'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HMO consuming bacteria', 'description': 'Infants will given a daily HMO consuming probiotic (B. infantis) for four weeks', 'interventionNames': ['Dietary Supplement: B. longum subsp. infantis']}, {'type': 'EXPERIMENTAL', 'label': 'Non-HMO consuming bacteria', 'description': 'Infants will be given a daily non-HMO consuming probiotic (L. reuteri) for four weeks', 'interventionNames': ['Dietary Supplement: L. reuteri probiotic']}], 'interventions': [{'name': 'B. longum subsp. infantis', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Infants will receive 1 dose of a B. infantis probiotic daily for 4 weeks', 'armGroupLabels': ['HMO consuming bacteria']}, {'name': 'L. reuteri probiotic', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Infants will receive 1 dose of an L. reuteri probiotic daily for 4 weeks', 'armGroupLabels': ['Non-HMO consuming bacteria']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Diana Taft, BA, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}