A Randomized, Parallel, Double Blind, Placebo Controlled Clinical Study Evaluating the Effect of Probiotic Formula on Immune System in Preschool Children
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Immune System Support
- Sponsor
- Deerland Enzymes
- Enrollment
- 102
- Locations
- 5
- Primary Endpoint
- The incidence of gastrointestinal and/or respiratory infections for experimental group compared to control group
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
Healthy preschool children will be recruited, gastrointestinal infection and respiratory infection symptoms will be followed during the 8-week treatment and 4-week follow-up period, to evaluate the effect of the used probiotic formula on immune system in comparison to the group using placebo.
Investigators
Eligibility Criteria
Inclusion Criteria
- •signed informed consent by at least one parent or legal guardian
- •children aged 2 to 6 years
- •attending or about to start attending day-care
Exclusion Criteria
- •body weight at birth \<2500g
- •gestational age \<37 weeks
- •severe chronic illness
- •regular use of medication
- •immunodeficiency
- •parent or legal guardian not able to understand and comply with requirements of the study
Outcomes
Primary Outcomes
The incidence of gastrointestinal and/or respiratory infections for experimental group compared to control group
Time Frame: 12-week study period (consisting of 8-week treatment plus 4-week follow-up)
Number of participants with at least one occurrence of gastrointestinal and/or respiratory infections during 12-week study period in the experimental group compared to control group.
The incidence of adverse events occuring in the experimental group compared to control group
Time Frame: 12-week study period (consisting of 8-week treatment plus 4-week follow-up)
Number of participants with treatment related adverse events during 12-week study period for both, experimental and control group.