Evaluation of Probiotics on Symptoms of Upper Respiratory Tract Infections

This study has been completed.
Sponsor:
Information provided by:
Danisco
ClinicalTrials.gov Identifier:
NCT00599430
First received: January 3, 2008
Last updated: January 11, 2008
Last verified: January 2008
  Purpose

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.


Condition Intervention
Healthy
Dietary Supplement: Placebo
Dietary Supplement: Lactobacillus acidophilus NCFM
Dietary Supplement: Combination of Lactobacillus acidophilus and Bifidobacterium lactis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Probiotics and Effects on Illness-Related Symptoms for Pre-School Age Children

Resource links provided by NLM:


Further study details as provided by Danisco:

Primary Outcome Measures:
  • 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. [ Time Frame: Daily for six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine if children who consume a beverage fortified with a probiotic miss fewer days of preschool as measured by illness. [ Time Frame: Six months ] [ Designated as safety issue: No ]

Enrollment: 326
Study Start Date: November 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo
Dietary Supplement: Placebo
Inert excipient
Active Comparator: Active 1
One probiotic strain
Dietary Supplement: Lactobacillus acidophilus NCFM
1e10 CFU/day
Active Comparator: Active 2
Blend of two strains
Dietary Supplement: Combination of Lactobacillus acidophilus and Bifidobacterium lactis
1x10e10 CFU/day

  Eligibility

Ages Eligible for Study:   3 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00599430

Locations
China, Zhejiang
Day care center
Jinhua City, Zhejiang, China
Sponsors and Collaborators
Danisco
Investigators
Study Director: Charlie Zhang Sprim Advanced Life Sciences
Study Chair: Cheryl Riefer Sprim Advanced Life Sciences
  More Information

No publications provided by Danisco

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gregory Leyer / Probiotic Technical Director, Danisco
ClinicalTrials.gov Identifier: NCT00599430     History of Changes
Other Study ID Numbers: Danisco - Mao, 06-02-D-011
Study First Received: January 3, 2008
Last Updated: January 11, 2008
Health Authority: China: Ministry of Health

Keywords provided by Danisco:
Probiotic
Lactobacillus
NCFM
Bifidobacterium
Healthy children

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 23, 2014