Evaluation of Probiotics on Symptoms of Upper Respiratory Tract Infections

Danisco

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Lactobacillus acidophilus NCFM; Dietary Supplement: Combination of Lactobacillus acidophilus and Bifidobacterium lactis

Study type: Interventional

Funder types: Industry

Identifiers

NCT00599430

Danisco - Mao

06-02-D-011

Details and patient eligibility

About

The aim of the present prospective study is to investigate whether the consumption of certain probiotic strains over a six-month winter/spring season would be able to affect the incidence and duration of upper respiratory tract infections, in otherwise healthy children as well as determining whether a combination of two strains would perform differently from a single strain version.

Enrollment: 326 patients

Sex: All

Ages: 3 to 5 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children aged 3-5 years of normal nutritional status and health

Exclusion criteria

• Contraindications to dairy products (lactose intolerance or cow's milk allergy)
• Indicators of inflammatory disease, intestinal disease, Crohn's disease, colitis, celiac disease
• Chronic cough from recurring respiratory distress-related diseases
• Hirschsprung's disease
• Cystic fibrosis
• Other metabolic, neurological, or anatomic alteration that predisposes participation
• Intake of probiotics within the last 3 weeks

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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326 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: Placebo

Active 1

Active Comparator group

Description:

One probiotic strain

Treatment:

Dietary Supplement: Lactobacillus acidophilus NCFM

Active 2

Active Comparator group

Description:

Blend of two strains

Treatment:

Dietary Supplement: Combination of Lactobacillus acidophilus and Bifidobacterium lactis