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:
University of Florida
Organization:
Study Overview
Official Title:
B2BBB: Baby 2 Baby Beneficial Bacteria
Status:
TERMINATED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to recruit a sufficient number of women in one month to start the lactation support groups.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: