NCT05973812

Brief Summary

The objective of this work was the characterization of the probiotic potential of Bifidobacterium breve PS1, a strain originally isolated from human milk. Subsequently, its safety and tolerance were evaluated in a trial including healthy, formula-fed 3-months-old infants. A total of 187 infants were randomized into two groups: probiotic group (PG) and control group (CG). Both groups received the same infant formula but, in the case of the PG, it was supplemented with the strain. A total of 160 infants (80 per group) completed the three months of intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2012

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2015

Completed
8.4 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 3, 2023

Completed
Last Updated

August 3, 2023

Status Verified

July 1, 2023

Enrollment Period

1.6 years

First QC Date

July 16, 2023

Last Update Submit

July 25, 2023

Conditions

Infant DevelopmentSafety Issues

Outcome Measures

Primary Outcomes (3)

  • Weight gain

    Measurement of weight gain (kg)

    3 months

  • Length

    Measurement of length (cm)

    3 months

  • Head circumference

    Measurement of head circumference (cm)

    3 months

Secondary Outcomes (2)

  • Modification of the fecal microbiota

    3 months

  • Modification of the fecal concentration of short-chain fatty acids

    3 months

Study Arms (2)

Probiotic group

EXPERIMENTAL

All infants (3-months-old) in the probiotic group consumed an infant formula supplemented with a freeze-dried probiotic (7 log10 colony-forming units \[CFU\] of B. breve PS1 per gram of formula) for 3 months.

Dietary Supplement: Infant formula supplemented with Bifidobacterium breve PS1

Control group

SHAM COMPARATOR

All infants (3-months-old) in the control group consumed the same infant formula but without probiotic supplementation.

Dietary Supplement: Infant formula NOT supplemented with Bifidobacterium breve PS1

Interventions

Infant formula supplemented with Bifidobacterium breve PS1DIETARY_SUPPLEMENT

Feeding with an infant formula containing 7 log10 cfu of the strain per gram of formula.

Probiotic group
Infant formula NOT supplemented with Bifidobacterium breve PS1DIETARY_SUPPLEMENT

Feeding with the same infant formula but without supplementation with the B. breve strain

Control group

Eligibility Criteria

Age3 Months - 3 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy 3-months-old infants
  • Formula-fed infants from birth

You may not qualify if:

  • History of mild or serious gastrointestinal disorders (history of chronic diarrhea or constipation, gastroesophageal reflux)
  • Gastrointestinal surgery
  • Cow's milk protein allergy
  • Metabolic disorders (diabetes, lactose intolerance)
  • Immune deficiency
  • Previous use of probiotic-containing formula.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital Gregorio Marañón

Madrid, 28007, Spain

Location

Universidad Complutense de Madrid

Madrid, 28040, Spain

Location

Centro de Atención Primaria Silvano

Madrid, 28043, Spain

Location

Study Officials

  • Juan M Rodríguez, PhD

    Universidad Complutense de Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Only one person of the research team (statistician) knew the correspondence between each reference (one reference per each subject) and the arm (probiotic or control). The codes were blinded for the participant, the care provider and the investigator.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Infants were classified into 2 groups. All infants in the probiotic group consumed an infant formula containing a freeze-dried probiotic (7 log10 CFU of B. breve PS1 per gram of formula). All infants in the control group consumed the same formula but without probiotic supplementation.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 16, 2023

First Posted

August 3, 2023

Study Start

December 12, 2012

Primary Completion

July 29, 2014

Study Completion

March 12, 2015

Last Updated

August 3, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

IPD will be available to other researchers once the study is published.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
All the data will be available to other researchers once the study is published.
Access Criteria
Data will be available after the publication of the study in an open access journal. They will be provided on request.

Locations

ES(3)