Effect of Probiotic Formula DE111® on Immune System in Preschool Children

A Randomized, Parallel, Double Blind, Placebo Controlled Clinical Study Evaluating the Effect of Probiotic Formula on Immune System in Preschool Children

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.

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