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Evaluation of Probiotics on Symptoms of Upper Respiratory Tract Infections

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00599430
First Posted: January 23, 2008
Last Update Posted: January 23, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Danisco
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Probiotics and Effects on Illness-Related Symptoms for Pre-School Age Children

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 ]

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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   3 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: January 3, 2008
First Posted: January 23, 2008
Last Update Posted: January 23, 2008
Last Verified: January 2008

Keywords provided by Danisco:
Probiotic
Lactobacillus
NCFM
Bifidobacterium
Healthy children

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