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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 20, 2014