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Evaluation of Probiotics on Symptoms of Upper Respiratory Tract Infections

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ClinicalTrials.gov Identifier: NCT00599430
Recruitment Status : Completed
First Posted : January 23, 2008
Last Update Posted : January 23, 2008
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Placebo Dietary Supplement: Lactobacillus acidophilus NCFM Dietary Supplement: Combination of Lactobacillus acidophilus and Bifidobacterium lactis Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 326 participants
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
Study Start Date : November 2005
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. 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 ]


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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

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

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 Posted: January 23, 2008    Key Record Dates
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