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Safety of Lactobacillus Fermentum in Newborn Infants

NCT01346644 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2013-05-16

No results posted yet for this study

Summary

In the last years manipulation of intestinal microbiota with probiotics has gained an increasing interest, specially in infant nutrition since recent studies has demonstrated the presence of probiotics in human milk. However, there are few studies studying the effects of probiotics in newborns. The objective of the present study is to analyze safety and tolerance of the probiotic Lactobacillus fermentum CECT5716 isolated from human milk.

Conditions

  • Tolerance

Interventions

OTHER

Infant formula

Powder infant formula

OTHER

Infant formula

Powder infant formula

Sponsors & Collaborators

  • Puleva Biotech

    lead INDUSTRY

Principal Investigators

  • Mercedes Gil, Doctor · Hospital Reina Sofía de Córdoba (Spain)

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Days
Max Age
30 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28

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 NCT01346644 on ClinicalTrials.gov