NCT05703659

Baby 2 Baby Beneficial Bacteria

B2BBB: Baby 2 Baby Beneficial Bacteria

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 62 Years
• Healthy volunteers: Accepted

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.

Conditions

• Transmission

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	B. longum subsp. infantis	Infants will receive 1 dose of a B. infantis probiotic daily for 4 weeks
DIETARY_SUPPLEMENT	L. reuteri probiotic	Infants will receive 1 dose of an L. reuteri probiotic daily for 4 weeks

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-10-29
• Completion: 2025-04-09
• First posted: 2023-01-30
• Last updated: 2025-08-01

Locations

1 site across 1 country: United States