Baby 2 Baby Beneficial Bacteria

B2BBB: Baby 2 Baby Beneficial Bacteria

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.

Study Overview

• Status: Terminated
• Conditions: Transmission
• Intervention / Treatment: Dietary supplement: B. longum subsp. infantis; Dietary supplement: L. reuteri probiotic

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 62 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

NOTE: Age limits listed are for mothers. For infants, age limits are a minimum of 1 day and a maximum of 1 month

Inclusion Criteria:

• Healthy singleton pregnancy, term delivery (>= 36 weeks corrected gestational age)
• 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)
• 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.

Exclusion Criteria:

• Maternal drug abuse
• Infant congenital abnormalities
• 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)
• Intent to provide a non-study probiotics to the infant
• Known immunocompromised status of the infant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HMO consuming bacteria; Infants will given a daily HMO consuming probiotic (B. infantis) for four weeks	Dietary supplement: B. longum subsp. infantis; Infants will receive 1 dose of a B. infantis probiotic daily for 4 weeks
Experimental: Non-HMO consuming bacteria; Infants will be given a daily non-HMO consuming probiotic (L. reuteri) for four weeks	Dietary supplement: L. reuteri probiotic; Infants will receive 1 dose of an L. reuteri probiotic daily for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transmission of probiotics to non-supplemented infants	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.	4 weeks

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Diana Taft, BA, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): October 29, 2024
• Study Completion (Actual): April 9, 2025

Study Registration Dates

• First Submitted: January 19, 2023
• First Submitted That Met QC Criteria: January 19, 2023
• First Posted (Actual): January 30, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2025
• Last Update Submitted That Met QC Criteria: July 29, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Probiotic; Transmission; L. reuteri; Beneficial bacteria; B. longum subsp. infantis; breastfed infants
• Additional Relevant MeSH Terms: Anti-Infective Agents; Antimalarials; Antiprotozoal Agents; Antiparasitic Agents; Anti-Infective Agents, Urinary; Sulfalene
• Other Study ID Numbers: IRB202200652

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No