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

Puleva Biotech

Status and phase: Completed; Phase 1

Conditions: Infection

Treatments: Dietary Supplement: follow on formula with Lactobacillus salivarius CECT5713; Dietary Supplement: follow on formula without probiotics

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00724204

Safety Salivarius

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 6 to 6 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy six months old children

Exclusion criteria

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

Trial design

80 participants in 2 patient groups, including a placebo group

A

Placebo Comparator group

Description:

Children that consumed a follow on formula without Lactobacillus salivarius CECT5713

Treatment:

Dietary Supplement: follow on formula without probiotics

B

Active Comparator group

Description:

Children that consumed a follow on formula with Lactobacillus salivarius CECT5713

Treatment:

Dietary Supplement: follow on formula with Lactobacillus salivarius CECT5713