Evaluation of Probiotics on Symptoms of Upper Respiratory Tract Infections
Probiotics and Effects on Illness-Related Symptoms for Pre-School Age Children
2 other identifiers
interventional
326
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy
Started Nov 2005
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 3, 2008
CompletedFirst Posted
Study publicly available on registry
January 23, 2008
CompletedJanuary 23, 2008
January 1, 2008
6 months
January 3, 2008
January 11, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Daily for six months
Secondary Outcomes (1)
To determine if children who consume a beverage fortified with a probiotic miss fewer days of preschool as measured by illness.
Six months
Study Arms (3)
1
PLACEBO COMPARATORPlacebo
Active 1
ACTIVE COMPARATOROne probiotic strain
Active 2
ACTIVE COMPARATORBlend of two strains
Interventions
1x10e10 CFU/day
Eligibility Criteria
You may qualify if:
- Children aged 3-5 years of normal nutritional status and health
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daniscolead
Study Sites (1)
Day care center
Jinhua, Zhejiang, China
Related Publications (1)
Leyer GJ, Li S, Mubasher ME, Reifer C, Ouwehand AC. Probiotic effects on cold and influenza-like symptom incidence and duration in children. Pediatrics. 2009 Aug;124(2):e172-9. doi: 10.1542/peds.2008-2666. Epub 2009 Jul 27.
PMID: 19651563DERIVED
Study Officials
- STUDY DIRECTOR
Charlie Zhang
Sprim Advanced Life Sciences
- STUDY CHAIR
Cheryl Riefer
Sprim Advanced Life Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 3, 2008
First Posted
January 23, 2008
Study Start
November 1, 2005
Primary Completion
May 1, 2006
Study Completion
May 1, 2006
Last Updated
January 23, 2008
Record last verified: 2008-01