Trial | NCT01510938  Report issue

Title

Probiotics in Respiratory Tract Infections in Children
Role of Probiotics in Prevention of Respiratory Tract Infections in Preschool and Primary School Children

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    242
The purpose of this study is to assess the potential of probiotics in prevention of respiratory tract infections and their complications in children
Study Started
Jan 31
2012
Primary Completion
May 31
2012
Study Completion
Dec 31
2012
Last Update
Dec 30
2013
Estimate

Dietary Supplement L. acidophilus DDS-1, B. lactis UABLA-12

1 g of probiotic will be reconstituted in 25-50 ml tepid water, juice or age specific baby food and immediately fed once a day (5 billion CFU/daily) for 2-weeks trial period or to the end of acute respiratory infection depending on whatever is longer.

  • Other names: DDS-Junior

Dietary Supplement Placebo

1 g in 25-50 ml of tepid water or juice fed once a day for 2-weeks trial period or to the end of acute respiratory infection depending on whatever is longer.

  • Other names: Rice maltodextrin

Placebo Placebo Comparator

1 g of rice maltodextrin will be reconstituted in 25-50 ml of tepid water or juice and immediately fed once a day for 2-weeks trial period or to the end of acute respiratory infection depending on whatever is longer.

Probiotic Experimental

powder of L. acidophilus DDS-1, B. lactis UABLA-12, 50 mg of fructooligosaccharide 1 g of probiotic will be reconstituted in 25-50 ml tepid water or juice and immediately fed once a day (5 billion CFU/daily) for 2-weeks trial period or to the end of acute respiratory infection depending on whatever is longer.

Criteria 

Inclusion Criteria:

Age 3-12 yrs
At least one episode of respiratory tract infection in the previous epidemiological season
Direct telephone access available
Informed consent signed

Exclusion Criteria:

Vaccination against the influenza
Chronic adeno-tonsillar pathology
Recurrent otitis
Sinusitis
Respiratory allergy
Acute or chronic intestinal disease with diarrhea and/or malabsorption syndrome
Lactose intolerance
Functional or organic constipation
Down syndrome
Congenital or acquired heart disease
Cerebral palsy
Any chronic hepatic, renal, metabolic, or immune system disease
No Results Posted