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Effect of a Follow on Formula With Lactobacillus Fermentum on the Incidence of Infections

Primary Purpose

Incidence of Infectious Diseases

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Lactobacillus fermentum
Follow on formula without probiotics
Sponsored by
Puleva Biotech
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Incidence of Infectious Diseases

Eligibility Criteria

6 Months - 7 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 6 months old children born at term
  • written consent from parents

Exclusion Criteria:

  • frequent gastrointestinal disorders (frequent diarrhoeas, constipation episodes, gastroesophageal reflux)
  • gastrointestinal surgery
  • cow's milk protein allergy
  • metabolic diseases (diabetes or lactose intolerance)
  • immune deficiency
  • antibiotic treatment during the trial and/or recent (within the preceding 3 weeks)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Probiotic

    Control

    Arm Description

    follow on formula with the probiotic Lactobacillus fermentum

    follow on formula without probiotics

    Outcomes

    Primary Outcome Measures

    Incidence of infectious diseases

    Secondary Outcome Measures

    Full Information

    First Posted
    October 5, 2010
    Last Updated
    October 6, 2010
    Sponsor
    Puleva Biotech
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01215656
    Brief Title
    Effect of a Follow on Formula With Lactobacillus Fermentum on the Incidence of Infections
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2008 (undefined)
    Primary Completion Date
    January 2010 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Puleva Biotech

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The objective of the study is to evaluate the effects of a follow on formula containing the human milk probiotic Lactobacillus fermentum on the incidence of infection in 6 months old infants.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Incidence of Infectious Diseases

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    188 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Probiotic
    Arm Type
    Experimental
    Arm Description
    follow on formula with the probiotic Lactobacillus fermentum
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    follow on formula without probiotics
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Lactobacillus fermentum
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Follow on formula without probiotics
    Primary Outcome Measure Information:
    Title
    Incidence of infectious diseases

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    7 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 6 months old children born at term written consent from parents Exclusion Criteria: frequent gastrointestinal disorders (frequent diarrhoeas, constipation episodes, gastroesophageal reflux) gastrointestinal surgery cow's milk protein allergy metabolic diseases (diabetes or lactose intolerance) immune deficiency antibiotic treatment during the trial and/or recent (within the preceding 3 weeks)

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21873895
    Citation
    Maldonado J, Canabate F, Sempere L, Vela F, Sanchez AR, Narbona E, Lopez-Huertas E, Geerlings A, Valero AD, Olivares M, Lara-Villoslada F. Human milk probiotic Lactobacillus fermentum CECT5716 reduces the incidence of gastrointestinal and upper respiratory tract infections in infants. J Pediatr Gastroenterol Nutr. 2012 Jan;54(1):55-61. doi: 10.1097/MPG.0b013e3182333f18. Erratum In: J Pediatr Gastroenterol Nutr. 2012 Apr;54(4):571.
    Results Reference
    derived

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    Effect of a Follow on Formula With Lactobacillus Fermentum on the Incidence of Infections

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