Safety of Lactobacillus Fermentum in Newborn Infants

Puleva Biotech137 enrolled

Overview

In the last years manipulation of intestinal microbiota with probiotics has gained an increasing interest, specially in infant nutrition since recent studies has demonstrated the presence of probiotics in human milk. However, there are few studies studying the effects of probiotics in newborns. The objective of the present study is to analyze safety and tolerance of the probiotic Lactobacillus fermentum CECT5716 isolated from human milk.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

137

Conditions

Tolerance

Interventions

Infant formulaOTHER

Powder infant formula

Infant formulaOTHER

Powder infant formula

Eligibility

Sex: ALLMin age: 21 DaysMax age: 30 Days

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy 1 month infants exclusively formula-fed Exclusion Criteria: * gastrointestinal disorders (history of chronic diarrhoea or constipation, gastroesophageal reflux) * gastrointestinal surgery * cow's milk protein allergy * metabolic disorders (diabetes, lactose intolerance) * immune deficiency * antibiotic prescription 1-week prior to inclusion and previous use of formula containing prebiotics or probiotics

Locations (1)

Biosearch Life

Granada, Granada, Spain

Outcomes

Primary Outcomes

average weight gain

Time frame: 4 months

Secondary Outcomes

growth and health of infants

average weight, length of infants. Incidence of infections. Incidence of allergic diseases

Time frame: 2,4,6,12 and 36 months of life

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.