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

Puleva Biotech188 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

188

Conditions

Incidence of Infectious Diseases

Interventions

Lactobacillus fermentumDIETARY_SUPPLEMENT

Follow on formula without probioticsDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 7 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Incidence of infectious diseases

Data from ClinicalTrials.gov

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