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Completed

NCT Number: NCT00724204

Safety Assessment of Lactobacillus Salivarius CECT5713 in 6 Months Old Children

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.

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Key information

Conditions

Infection Infections

Age range

6 month–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hospital Universitario San Cecilio

Granada, 18012, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy six months old children

Exclusion criteria

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

Treatment and study plan

Follow on formula without probiotics

Dietary Supplement

A follow on formula without probiotics

follow on formula with Lactobacillus salivarius CECT5713

Dietary Supplement

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

Primary outcomes

  1. Adverse reactions

    Time frame: 3 months and 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Puleva Biotech

Industry

Collaborators

  • Hospital Clinico Universitario San Cecilio

Registry information

Official study title

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

Acronym: P010

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jul 29, 2008
Registry last updated
Jul 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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