Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
242 participants
INTERVENTIONAL
2012-01-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Placebo
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.
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.
Probiotic
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.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least one episode of respiratory tract infection in the previous epidemiological season
* Direct telephone access available
* Informed consent signed
Exclusion Criteria
* 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
3 Years
12 Years
ALL
Yes
Sponsors
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Lviv National Medical University
OTHER
Responsible Party
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Sergei V. Gerasimov, MD, PhD
Associate Professor of Pediatrics
Principal Investigators
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Sergei V Gerasimov, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Lviv National Medical University
Locations
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Lviv City Children Hospital
Lviv, Lviv Oblast, Ukraine
Countries
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Other Identifiers
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SG-11009
Identifier Type: -
Identifier Source: org_study_id