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

This study has been completed.
Sponsor:
Collaborator:
Hospital Clinico Universitario San Cecilio
Information provided by:
Puleva Biotech
ClinicalTrials.gov Identifier:
NCT00724204
First received: July 28, 2008
Last updated: NA
Last verified: July 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Infection
Dietary Supplement: follow on formula without probiotics
Dietary Supplement: follow on formula with Lactobacillus salivarius CECT5713
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Functional Evaluation of a Follow on Formula Supplemented With Lactobacillus Salivarius CECT5713

Resource links provided by NLM:


Further study details as provided by Puleva Biotech:

Primary Outcome Measures:
  • Adverse reactions [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • growth parameters (height, length, head circumference) [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: Yes ]
  • Fecal microbiota [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]
  • Fecal short chain fatty acids [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: April 2006
Study Completion Date: December 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   6 Months to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy six months old children

Exclusion Criteria:

  • Lactose intolerance
  • Cow's milk protein allergy
  • Serious metabolic diseases
  • Antibiotic treatment
  • Serious gastrointestinal diseases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00724204

Locations
Spain
Hospital Universitario San Cecilio
Granada, Spain, 18012
Sponsors and Collaborators
Puleva Biotech
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
  More Information

No publications provided by Puleva Biotech

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Federico Lara-Villoslada, Puelav Biotech
ClinicalTrials.gov Identifier: NCT00724204     History of Changes
Other Study ID Numbers: Safety Salivarius
Study First Received: July 28, 2008
Last Updated: July 28, 2008
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Puleva Biotech:
probiotics
safety
fecal microbiota
infections

ClinicalTrials.gov processed this record on August 28, 2014