TERMINATED

Baby 2 Baby Beneficial Bacteria

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

B2BBB: Baby 2 Baby Beneficial Bacteria

Quick Facts

Study Start:2023-03-01
Study Completion:2025-04-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT05703659

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 62 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Healthy singleton pregnancy, term delivery (\>= 36 weeks corrected gestational age)
  2. * 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)
  3. * 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.
  1. * Maternal drug abuse
  2. * Infant congenital abnormalities
  3. * 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)
  4. * Intent to provide a non-study probiotics to the infant
  5. * Known immunocompromised status of the infant.

Contacts and Locations

Principal Investigator

Diana Taft, BA, PhD
PRINCIPAL_INVESTIGATOR
University of Florida

Study Locations (Sites)

University of Florida
Gainesville, Florida, 32611
United States

Collaborators and Investigators

Sponsor: University of Florida

  • Diana Taft, BA, PhD, PRINCIPAL_INVESTIGATOR, University of Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-01
Study Completion Date2025-04-09

Study Record Updates

Study Start Date2023-03-01
Study Completion Date2025-04-09

Terms related to this study

Keywords Provided by Researchers

  • Transmission
  • Beneficial bacteria
  • Probiotic
  • B. longum subsp. infantis
  • L. reuteri
  • breastfed infants

Additional Relevant MeSH Terms

  • Transmission