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

Phase 2

Completed

• Conditions: Incidence of Infectious Diseases
• Interventions: Dietary Supplement: Lactobacillus fermentum; Dietary Supplement: Follow on formula without probiotics

• Registration Number: NCT01215656
• Lead Sponsor: Puleva Biotech

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Primary Completion: 2010-01
• Status Verified: 2010-10
• Study First Submitted: 2010-10-05
• Study First Submitted QC: 2010-10-05
• Study First Posted: 2010-10-06
• Last Update Submitted: 2010-10-06
• Last Update Posted: 2010-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Lactobacillus fermentum	follow on formula with the probiotic Lactobacillus fermentum
Control	Follow on formula without probiotics	follow on formula without probiotics

Primary Outcome Measures

Name	Time	Method
Incidence of infectious diseases