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Safety of Lactobacillus Fermentum in Newborn Infants

This study has been completed.
Sponsor:
Information provided by:
Puleva Biotech
ClinicalTrials.gov Identifier:
NCT01346644
First received: May 1, 2011
Last updated: May 15, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention
Tolerance
 Other: Infant formula

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Study of Tolerance of an Infant Formula Supplemented With Lactobacillus Fermentum CECT5716

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Puleva Biotech:

Primary Outcome Measures:
  • average weight gain [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • growth and health of infants [ Time Frame: 2,4,6,12 and 36 months of life ] [ Designated as safety issue: Yes ]
    average weight, length of infants. Incidence of infections. Incidence of allergic diseases


Enrollment: 137
Study Start Date: February 2009
Arms Assigned Interventions
Active Comparator: No probiotics
Infant formula with no probiotics
 Other: Infant formula
Powder infant formula
Experimental: Probiotic
Infant formula supplemented with probiotic
 Other: Infant formula
Powder infant formula

  Eligibility

Ages Eligible for Study:   up to 30 Days
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Healthy 1 month infants exclusively formula-fed

Exclusion Criteria:

  • gastrointestinal disorders (history of chronic diarrhoea or constipation, gastroesophageal reflux)
  • gastrointestinal surgery
  • cow's milk protein allergy
  • metabolic disorders (diabetes, lactose intolerance)
  • immune deficiency
  • antibiotic prescription 1-week prior to inclusion and previous use of formula containing prebiotics or probiotics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01346644

Locations
Spain
Biosearch Life
Granada, Spain, 18004
Sponsors and Collaborators
Puleva Biotech
Investigators
Principal Investigator: Mercedes Gil, Doctor Hospital Reina Sofía de Córdoba (Spain)
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01346644     History of Changes
Other Study ID Numbers: P024
Study First Received: May 1, 2011
Last Updated: May 15, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Puleva Biotech:
Probiotic
infant nutrition
safety
infections

ClinicalTrials.gov processed this record on May 16, 2013