Safety Assessment of Lactobacillus Salivarius CECT5713 in 6 Months Old Children

Infection Clinical Trial

— P010  

Official title:

Functional Evaluation of a Follow on Formula Supplemented With Lactobacillus Salivarius CECT5713

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00724204
• Other study ID #: Safety Salivarius
• Status: Completed
• Phase: Phase 1
• First received: July 28, 2008
• Last updated: July 28, 2008
• Start date: April 2006
• Est. completion date: December 2007

Study information

• Verified date: July 2008
• Source: Puleva Biotech
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

The aim of the trial is to evaluate safety of a follow on formula supplemented with Lactobacillus salivarius CECT5713. A randomized double blind placebo controlled trial was carried out. Eighty six months old children were recruited by the department of pediatrics of Hospital Univeristario San Cecilio. Children were divided in two groups that consumed a follow on formula supplemented or not with the probiotic strain during 6 months. Fecal samples were obtained at the recruitment, at 3 months and at the end of the trial. In addition revision by the pediatrician was performed once a month and possible adverse effects were recorded both by the pediatrician and by parents.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 6 Months

Eligibility

Inclusion Criteria:

• Healthy six months old children

Exclusion Criteria:

• Lactose intolerance

• Cow's milk protein allergy

• Serious metabolic diseases

• Antibiotic treatment

• Serious gastrointestinal diseases

Study Design

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

Related Conditions & MeSH terms

• Infection

Intervention

Dietary Supplement:
• follow on formula without probiotics
A follow on formula without probiotics
• follow on formula with Lactobacillus salivarius CECT5713
follow on formula with Lactobacillus salivarius CECT5713 in a dose of 2x10E8 cfu/day

Locations

Country	Name	City	State
Spain	Hospital Universitario San Cecilio	Granada

Sponsors (2)

Lead Sponsor	Collaborator
Puleva Biotech	Hospital Clinico Universitario San Cecilio

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse reactions		3 months and 6 months	Yes
Secondary	growth parameters (height, length, head circumference)		3 months and 6 months	Yes
Secondary	Fecal microbiota		3 months and 6 months	No
Secondary	Fecal short chain fatty acids		3 months and 6 months	No