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NCT01346644 Clinical Trial

Safety of Lactobacillus Fermentum in Newborn Infants

Tolerance Clinical Trial

Official title:
Study of Tolerance of an Infant Formula Supplemented With Lactobacillus Fermentum CECT5716

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01346644
Other study ID # P024
Secondary ID
Status Completed
Phase N/A
First received May 1, 2011
Last updated May 15, 2013
Start date February 2009

Study information
Verified date May 2013
Source Puleva Biotech
Contact n/a
Is FDA regulated No
Health authority Spain: Comité Ético de Investigación Clínica
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 137
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group N/A to 30 Days
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

Intervention

Other:
• Infant formula
Powder infant formula
• Infant formula
Powder infant formula

Locations
Country Name City State
Spain Biosearch Life Granada

Sponsors (1)
Lead Sponsor Collaborator
Puleva Biotech

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary average weight gain 4 months Yes
Secondary growth and health of infants average weight, length of infants. Incidence of infections. Incidence of allergic diseases 2,4,6,12 and 36 months of life Yes
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