Evaluation of Probiotics on Symptoms of Upper Respiratory Tract Infections

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Lactobacillus acidophilus NCFM; Dietary Supplement: Combination of Lactobacillus acidophilus and Bifidobacterium lactis

• Registration Number: NCT00599430
• Lead Sponsor: Danisco

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Primary Completion: 2006-05
• Study Completion: 2006-05
• Status Verified: 2008-01
• Study First Submitted: 2008-01-03
• Study First Submitted QC: 2008-01-11
• Last Update Submitted: 2008-01-11
• Study First Posted: 2008-01-23
• Last Update Posted: 2008-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 326

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	Placebo
Active 1	Lactobacillus acidophilus NCFM	One probiotic strain
Active 2	Combination of Lactobacillus acidophilus and Bifidobacterium lactis	Blend of two strains

Primary Outcome Measures

Name	Time	Method
To examine if the consumption of two different probiotic strains added to milk at the point of consumption could reduce the "flu-like" symptoms and other symptoms of illness of preschool-age children in day care centers.	Daily for six months

Secondary Outcome Measures

Name	Time	Method
To determine if children who consume a beverage fortified with a probiotic miss fewer days of preschool as measured by illness.	Six months

Trial Locations

Locations (1)

Day care center; 🇨🇳 Jinhua City, Zhejiang, China