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

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ClinicalTrials.gov Identifier: NCT00724204
Recruitment Status : Completed
First Posted : July 29, 2008
Last Update Posted : July 29, 2008
Sponsor:
Collaborator:
Hospital Clinico Universitario San Cecilio
Information provided by:
Puleva Biotech

Brief 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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Functional Evaluation of a Follow on Formula Supplemented With Lactobacillus Salivarius CECT5713
Study Start Date : April 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Adverse reactions [ Time Frame: 3 months and 6 months ]

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


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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

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

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 Posted: July 29, 2008    Key Record Dates
Last Update Posted: July 29, 2008
Last Verified: July 2008

Keywords provided by Puleva Biotech:
probiotics
safety
fecal microbiota
infections