TransmissionNCT05703659
Baby 2 Baby Beneficial Bacteria
A study testing B. longum subsp. infantis and L. reuteri probiotic in people with Transmission, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 62 yearsHealthy volunteers can take part
- Conditions the study is for
- Transmission
- What is being tested?
- B. longum subsp. infantis and L. reuteri probiotic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 9 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 62 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- B. longum subsp. infantis, L. reuteri probiotic
- Keywords
- Transmission, Beneficial bacteria, Probiotic, B. longum subsp. infantis, L. reuteri, breastfed infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B. longum subsp. infantisDietary supplement
Infants will receive 1 dose of a B. infantis probiotic daily for 4 weeks
L. reuteri probioticDietary supplement
Infants will receive 1 dose of an L. reuteri probiotic daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| HMO consuming bacteria | Experimental | Infants will given a daily HMO consuming probiotic (B. infantis) for four weeks Receives: Dietary Supplement: B. longum subsp. infantis |
| Non-HMO consuming bacteria | Experimental | Infants will be given a daily non-HMO consuming probiotic (L. reuteri) for four weeks Receives: Dietary Supplement: L. reuteri probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start1 Mar 2023
- Primary completion29 Oct 2024
- Study completion9 Apr 2025
Why it stopped: Unable to recruit a sufficient number of women in one month to start the lactation support groups.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TransmissionStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Primary Purpose of this study is epidemiological, and to determine if probiotic species can transmit between infants whose microbiomes are still developing. Mothers and infant dyads will be enrolled and attend 5 weekly lactation support group sessions. After the first session, infants will be randomized to receive 1 of 2 probiotics. Both probiotics are marketed in the US as dietary supplements for infants. At the first support group session and at the final session, infant fecal samples and mother's milk samples will be collected and tested for detectable levels of both probiotics to determine if horizontal transmission of the probiotic species occurred in the setting of a lactation support group.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diana Taft, BA, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05703659
- Sponsor's protocol ID
- IRB202200652
- Status last verified
- Jul 2025
- First submitted
- 19 Jan 2023
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- B2BBB: Baby 2 Baby Beneficial Bacteria
- ClinicalTrials.gov ID
- NCT05703659
- Acronym / sponsor ID
- IRB202200652
- Conditions
- Transmission
- Keywords
- Transmission, Beneficial bacteria, Probiotic, B. longum subsp. infantis, L. reuteri, breastfed infants
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit a sufficient number of women in one month to start the lactation support groups.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 29 Oct 2024 (actual)
- Study completion
- 9 Apr 2025 (actual)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Primary Purpose of this study is epidemiological, and to determine if probiotic species can transmit between infants whose microbiomes are still developing. Mothers and infant dyads will be enrolled and attend 5 weekly lactation support group sessions. After the first session, infants will be randomized to receive 1 of 2 probiotics. Both probiotics are marketed in the US as dietary supplements for infants. At the first support group session and at the final session, infant fecal samples and mother's milk samples will be collected and tested for detectable levels of both probiotics to determine if horizontal transmission of the probiotic species occurred in the setting of a lactation support group.
| Arm | Type | Receives |
|---|---|---|
| HMO consuming bacteria | Experimental | Dietary Supplement: B. longum subsp. infantisInfants will given a daily HMO consuming probiotic (B. infantis) for four weeks |
| Non-HMO consuming bacteria | Experimental | Dietary Supplement: L. reuteri probioticInfants will be given a daily non-HMO consuming probiotic (L. reuteri) for four weeks |
Who may qualify
- Ages
- 18 to 62 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B. longum subsp. infantisInfants will receive 1 dose of a B. infantis probiotic daily for 4 weeks | Dietary supplement | HMO consuming bacteria |
| L. reuteri probioticInfants will receive 1 dose of an L. reuteri probiotic daily for 4 weeks | Dietary supplement | Non-HMO consuming bacteria |
Primary outcome
Transmission of probiotics to non-supplemented infants
Time frame: 4 weeks
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.
Results and safety
The study was stopped early (reason given: Unable to recruit a sufficient number of women in one month to start the lactation support groups.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana Taft, BA, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B. longum subsp. infantis and L. reuteri probiotic in people with Transmission, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unable to recruit a sufficient number of women in one month to start the lactation support groups.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transmission of probiotics to non-supplemented infants (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.