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Safety of Bifidobacterium Breve PS1 for Infants

NCT05973812 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-08-03

No results posted yet for this study

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.

Conditions

  • Infant Development
  • Safety Issues

Interventions

DIETARY_SUPPLEMENT

Infant formula supplemented with Bifidobacterium breve PS1

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

DIETARY_SUPPLEMENT

Infant formula NOT supplemented with Bifidobacterium breve PS1

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

Sponsors & Collaborators

  • Hospital General Universitario Gregorio Marañon

    collaborator OTHER

  • Gerencia de Atención Primaria, Madrid

    collaborator OTHER_GOV

  • Universidad Complutense de Madrid

    lead OTHER

Principal Investigators

  • Juan M Rodríguez, PhD · Universidad Complutense de Madrid

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
3 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-12-12
Primary Completion
2014-07-29
Completion
2015-03-12

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05973812 on ClinicalTrials.gov