Safety of Lactobacillus Fermentum in Newborn Infants

Puleva Biotech

Status: Completed

Conditions: Tolerance

Treatments: Other: Infant formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT01346644

P024

Details and patient eligibility

About

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.

Enrollment: 137 patients

Sex: All

Ages: 21 to 30 days old

Volunteers: No Healthy Volunteers

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

Trial design

137 participants in 2 patient groups

No probiotics

Active Comparator group

Description:

Infant formula with no probiotics

Treatment:

Other: Infant formula

Other: Infant formula

Probiotic

Experimental group

Description:

Infant formula supplemented with probiotic

Treatment:

Other: Infant formula

Other: Infant formula