NCT00724204

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 29, 2008

Completed
Last Updated

July 29, 2008

Status Verified

July 1, 2008

Enrollment Period

1.4 years

First QC Date

July 28, 2008

Last Update Submit

July 28, 2008

Conditions

Infection

Keywords

probioticssafetyfecal microbiotainfections

Outcome Measures

Primary Outcomes (1)

  • Adverse reactions

    3 months and 6 months

Secondary Outcomes (3)

  • growth parameters (height, length, head circumference)

    3 months and 6 months

  • Fecal microbiota

    3 months and 6 months

  • Fecal short chain fatty acids

    3 months and 6 months

Study Arms (2)

A

PLACEBO COMPARATOR

Children that consumed a follow on formula without Lactobacillus salivarius CECT5713

Dietary Supplement: follow on formula without probiotics

B

ACTIVE COMPARATOR

Children that consumed a follow on formula with Lactobacillus salivarius CECT5713

Dietary Supplement: follow on formula with Lactobacillus salivarius CECT5713

Interventions

follow on formula without probioticsDIETARY_SUPPLEMENT

A follow on formula without probiotics

A
follow on formula with Lactobacillus salivarius CECT5713DIETARY_SUPPLEMENT

follow on formula with Lactobacillus salivarius CECT5713 in a dose of 2x10E8 cfu/day

B

Eligibility Criteria

Age6 Months - 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy six months old children

You may not qualify if:

  • Lactose intolerance
  • Cow's milk protein allergy
  • Serious metabolic diseases
  • Antibiotic treatment
  • Serious gastrointestinal diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario San Cecilio

Granada, Granada, 18012, Spain

Location

Related Publications (1)

  • Maldonado J, Lara-Villoslada F, Sierra S, Sempere L, Gomez M, Rodriguez JM, Boza J, Xaus J, Olivares M. Safety and tolerance of the human milk probiotic strain Lactobacillus salivarius CECT5713 in 6-month-old children. Nutrition. 2010 Nov-Dec;26(11-12):1082-7. doi: 10.1016/j.nut.2009.08.023. Epub 2009 Dec 16.

    PMID: 20018483DERIVED

MeSH Terms

Conditions

Infections

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • José A Maldonado, PhD, MD

    Department of Pediatrics. Hospital Universitario San Cecilio

    PRINCIPAL INVESTIGATOR

  • Mónica Olivares, PhD

    Department of Nutrition and Health. Puleva Biotech. Granada

    STUDY CHAIR

  • Federico Lara-Villoslada, PhD

    Department of Nutrition and Helath. Puleva Biotech. Granada

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 28, 2008

First Posted

July 29, 2008

Study Start

April 1, 2006

Primary Completion

September 1, 2007

Study Completion

December 1, 2007

Last Updated

July 29, 2008

Record last verified: 2008-07

Locations

ES(1)