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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00724204
First Posted: July 29, 2008
Last Update Posted: July 29, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Hospital Clinico Universitario San Cecilio
Information provided by:
Puleva Biotech
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • growth parameters (height, length, head circumference) [ Time Frame: 3 months and 6 months ]
  • Fecal microbiota [ Time Frame: 3 months and 6 months ]
  • Fecal short chain fatty acids [ Time Frame: 3 months and 6 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 6 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: July 28, 2008
First Posted: July 29, 2008
Last Update Posted: July 29, 2008
Last Verified: July 2008

Keywords provided by Puleva Biotech:
probiotics
safety
fecal microbiota
infections