Evaluation of Probiotics on Symptoms of Upper Respiratory Tract Infections

Healthy Clinical Trial

Official title:

Probiotics and Effects on Illness-Related Symptoms for Pre-School Age Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00599430
• Other study ID #: Danisco - Mao
• Secondary ID: 06-02-D-011
• Status: Completed
• Phase: N/A
• First received: January 3, 2008
• Last updated: January 11, 2008
• Start date: November 2005
• Est. completion date: May 2006

Study information

• Verified date: January 2008
• Source: Danisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 326
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 5 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy
• Respiratory Tract Infections

Intervention

Dietary Supplement:
• Placebo
Inert excipient
• Lactobacillus acidophilus NCFM
1e10 CFU/day
• Combination of Lactobacillus acidophilus and Bifidobacterium lactis
1x10e10 CFU/day

Locations

Country	Name	City	State
China	Day care center	Jinhua City	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Danisco

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To determine if children who consume a beverage fortified with a probiotic miss fewer days of preschool as measured by illness.		Six months	No