Baby 2 Baby Beneficial Bacteria

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Description

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.

Targeted Conditions

Study Overview

Start Date
March 1, 2023
Completion Date
January 18, 2025
Enrollment
60
Date Posted
January 30, 2023
Accepts Healthy Volunteers?
Yes
Gender
All

Locations

Full Address
University of Florida
Gainesville, Florida 32611, United States

Eligibility

Minimum Age (years)
18
Maximum Age (years)
62
Eligibility Criteria
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 Contact Info

Study Contact Name
Diana H Taft, PhD
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
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.
NCTid (if applicable)
NCT05703659