Safety of Lactobacillus Fermentum in Newborn Infants

This study has been completed.
Information provided by:
Puleva Biotech Identifier:
First received: May 1, 2011
Last updated: May 15, 2013
Last verified: May 2013
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
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:

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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01346644

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

No publications provided 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:
infant nutrition
infections processed this record on November 25, 2015