Safety of Lactobacillus Fermentum in Newborn Infants

Not Applicable

Completed

• Conditions: Tolerance

• Registration Number: NCT01346644
• Lead Sponsor: Puleva Biotech

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2011-05-01
• Study First Submitted QC: 2011-05-02
• Study First Posted: 2011-05-03
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-15
• Last Update Posted: 2013-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
average weight gain	4 months

Secondary Outcome Measures

Name	Time	Method
growth and health of infants	2,4,6,12 and 36 months of life	average weight, length of infants. Incidence of infections. Incidence of allergic diseases

Trial Locations

Locations (1)

Biosearch Life; 🇪🇸 Granada, Spain