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

Puleva Biotech

Status and phase: Completed; Phase 3; Phase 2

Conditions: Incidence of Infectious Diseases

Treatments: Dietary Supplement: Follow on formula without probiotics; Dietary Supplement: Lactobacillus fermentum

Study type: Interventional

Funder types: Industry

Identifiers

NCT01215656

L. fermentum infections

Details and patient eligibility

About

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.

Enrollment: 188 patients

Sex: All

Ages: 6 to 7 months old

Volunteers: Accepts 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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188 participants in 2 patient groups

Probiotic

Experimental group

Description:

follow on formula with the probiotic Lactobacillus fermentum

Treatment:

Dietary Supplement: Lactobacillus fermentum

Control

Active Comparator group

Description:

follow on formula without probiotics

Treatment:

Dietary Supplement: Follow on formula without probiotics