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Question
In hospitalised children (patients) does treatment with Lactobacillus rhamnosus GG (LGG) (treatment) prevent the development of nosocomial gastrointestinal or respiratory tract infections (outcome)?
Methods
Design
Randomised placebo-controlled trial.
Allocation
Computer generated random number list. Concealment method not explicitly stated.
Blinding
Double-blind.
Setting
Children's Hospital Zagreb.
Patients
Children older than 12 months admitted to hospital from November 2007 to May 2008. Excluded children with immunodeficiency, cow's milk allergy, cancer, chronic illness or anticipated hospital stay <3 days.
Intervention
376 children allocated to LGG product (109 CFU) in 100 ml of fermented milk product and 366 to fermented milk only (placebo), then monitored clinically each day with laboratory confirmation for nosocomial infections.
Outcomes
The number and severity of nosocomial gastrointestinal and respiratory infections and hospital length of stay.
Follow-up period
Up to 7 days after discharge.
Patient follow-up
360 (96%) children in the LGG group and 354 (97%) children in the …