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Safety of Lactobacillus Fermentum in Newborn Infants

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: May 3, 2011
Last Update Posted: May 16, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Puleva Biotech
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Study of Tolerance of an Infant Formula Supplemented With Lactobacillus Fermentum CECT5716

Resource links provided by NLM:

Further study details as provided by Puleva Biotech:

Primary Outcome Measures:
  • average weight gain [ Time Frame: 4 months ]

Secondary Outcome Measures:
  • growth and health of infants [ Time Frame: 2,4,6,12 and 36 months of life ]
    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


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01346644

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT01346644     History of Changes
Other Study ID Numbers: P024
First Submitted: May 1, 2011
First Posted: May 3, 2011
Last Update Posted: May 16, 2013
Last Verified: May 2013

Keywords provided by Puleva Biotech:
infant nutrition