Safety Assessment of Lactobacillus Salivarius CECT5713 in 6 Months Old Children (P010)

July 28, 2008 updated by: Puleva Biotech

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Granada, Spain, 18012
        • Hospital Universitario San Cecilio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: A
Children that consumed a follow on formula without Lactobacillus salivarius CECT5713
Dietary supplement: follow on formula without probiotics
A follow on formula without probiotics
Active Comparator: B
Children that consumed a follow on formula with Lactobacillus salivarius CECT5713
Dietary supplement: follow on formula with Lactobacillus salivarius CECT5713
follow on formula with Lactobacillus salivarius CECT5713 in a dose of 2x10E8 cfu/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse reactions
Time Frame: 3 months and 6 months
3 months and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
growth parameters (height, length, head circumference)
Time Frame: 3 months and 6 months
3 months and 6 months
Fecal microbiota
Time Frame: 3 months and 6 months
3 months and 6 months
Fecal short chain fatty acids
Time Frame: 3 months and 6 months
3 months and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Puleva Biotech

Collaborators

Hospital Clinico Universitario San Cecilio

Investigators

  • Principal Investigator: José A Maldonado, PhD, MD, Department of Pediatrics. Hospital Universitario San Cecilio
  • Study Chair: Mónica Olivares, PhD, Department of Nutrition and Health. Puleva Biotech. Granada
  • Study Director: Federico Lara-Villoslada, PhD, Department of Nutrition and Helath. Puleva Biotech. Granada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

July 28, 2008

First Submitted That Met QC Criteria

July 28, 2008

First Posted (Estimate)

July 29, 2008

Study Record Updates

Last Update Posted (Estimate)

July 29, 2008

Last Update Submitted That Met QC Criteria

July 28, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Safety Salivarius

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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