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Safety of Lactobacillus Fermentum in Newborn Infants

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.
ClinicalTrials.gov Identifier: NCT01346644
Recruitment Status : Completed
First Posted : May 3, 2011
Last Update Posted : May 16, 2013
Sponsor:
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment
Tolerance Other: Infant formula

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Study of Tolerance of an Infant Formula Supplemented With Lactobacillus Fermentum CECT5716
Study Start Date : February 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

Secondary Outcome Measures :
  1. 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


Eligibility Criteria

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
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

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


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