Baby 2 Baby Beneficial Bacteria | NCT05703659

Studies
Baby 2 Baby Beneficial Bacteria

NCT05703659

Sponsor

University of Florida

Status

Terminated

Last Update Posted

Aug 1, 2025Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Transmission

Interventions

B. longum subsp. infantis
L. reuteri probiotic

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Unable to recruit a sufficient number of women in one month to start the lactation support groups.

Expanded Access Info

Start Date

Mar 1, 2023Actual

Primary Completion Date

Oct 29, 2024Actual

Completion Date

Apr 9, 2025Actual

First Submitted Date

Jan 19, 2023

First Submission Date that Met QC Criteria

Jan 19, 2023

First Posted Date

Jan 30, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2025

Last Update Posted Date

Aug 1, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HMO consuming bacteria	Experimental	Infants will given a daily HMO consuming probiotic (B. infantis) for four weeks	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	Dietary Supplement: L. reuteri probiotic

Interventions

Name	Type	Description	Arm Group Labels	Other Names
B. longum subsp. infantis	Dietary Supplement	Infants will receive 1 dose of a B. infantis probiotic daily for 4 weeks	HMO consuming bacteria

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

62 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Diana Taft, BA, PhD	University of Florida	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Florida		Gainesville	Florida	32611	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention 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.