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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01510938
Other study ID # SG-11009
Secondary ID
Status Completed
Phase Phase 2
First received January 12, 2012
Last updated December 25, 2013
Start date January 2012
Est. completion date December 2012

Study information

Verified date December 2013
Source Lviv National Medical University
Contact n/a
Is FDA regulated No
Health authority Ukraine: Ministry of Health
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the potential of probiotics in prevention of respiratory tract infections and their complications in children


Recruitment information / eligibility

Status Completed
Enrollment 242
Est. completion date December 2012
Est. primary completion date May 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 3 Years to 12 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention


Intervention

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.
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.

Locations

Country Name City State
Ukraine Lviv City Children Hospital Lviv

Sponsors (1)

Lead Sponsor Collaborator
Lviv National Medical University

Country where clinical trial is conducted

Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of respiratory tract infection episodes in a child An episode will be defined as display of fever, cough, rhinitis, and sore throat or combination thereof for longer than 48 hours 1 month No
Secondary Duration of respiratory tract infection Time to CARIFS (Canadian Acute Respiratory Illness and Flu Scale) value 0 21 days No
Secondary Severity of respiratory tract infection a product of daily CARIFS times the duration of the disease 21 days No
Secondary Complications of respiratory tract infections Percent of otitis, sinusitis, bronchitis, pneumonia cases 21 days No
Secondary Antibiotic prescriptions Percent 21 days No
Secondary Hospitalization rate Number of hospitalizations 21 days No
Secondary Number of unscheduled doctor visits 21 days No
Secondary Number of days daycare/school missed 21 days No
Secondary Number of workdays missed by parents 21 days No
Secondary Time to resolution of individual CARIFS item Days to the correspondent CARIFS item 0 21 No
Secondary 25% and 50% decrease in the CARIFS score 25% and 50% decrease in the CARIFS score 21day No
Secondary Percent and duration of the use of over-the-counter medications Percent and duration of the use of over-the-counter medications 21day No
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