Back to resultsEffect 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
About this trial
This is an interventional prevention trial for Incidence of Infectious Diseases
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)
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
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
Learn more about this trial
Effect of a Follow on Formula With Lactobacillus Fermentum on the Incidence of Infections
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