Exploring beneficial bacteria transmission in infants through probiotics
B2BBB: Baby 2 Baby Beneficial Bacteria
This study is testing if giving infants a special probiotic can help pass beneficial bacteria from mothers' milk to their babies during lactation support groups.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 62 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT05703659 on ClinicalTrials.gov |
What this trial studies
This study recruits mother-infant pairs to participate in weekly lactation support groups over five weeks. Infants are randomized to receive either a probiotic that consumes human milk oligosaccharides (HMO) or one that does not. Researchers will collect stool samples from infants and milk samples from mothers before and after the support group sessions to analyze the transmission of beneficial bacteria using advanced sequencing techniques. The goal is to determine if specific probiotics can be transmitted between infants and if they can be detected in maternal milk.
Who should consider this trial
Good fit: Ideal candidates include healthy mothers with singleton pregnancies intending to exclusively breastfeed infants aged 1 day to 1 month.
Not a fit: Patients who may not benefit include those with maternal drug abuse issues or infants with congenital abnormalities.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of how beneficial bacteria are transmitted among infants, potentially improving infant gut health.
How similar studies have performed: While the approach of studying bacterial transmission through probiotics is gaining interest, this specific methodology appears to be novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Gainesville, Florida
- University of Florida — Gainesville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Diana Taft, BA, PhD — University of Florida
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.