Probiotics in Respiratory Tract Infections in Children

Phase 2

Completed

• Conditions: Infections, Respiratory Tract
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: L. acidophilus DDS-1, B. lactis UABLA-12

• Registration Number: NCT01510938
• Lead Sponsor: Lviv National Medical University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-12
• Study First Submitted QC: 2012-01-17
• Study First Posted: 2012-01-18
• Primary Completion: 2012-05
• Study Completion: 2012-12
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-25
• Last Update Posted: 2013-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 242

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Probiotic	L. acidophilus DDS-1, B. lactis UABLA-12	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.

Primary Outcome Measures

Name	Time	Method
Incidence of respiratory tract infection episodes in a child	1 month	An episode will be defined as display of fever, cough, rhinitis, and sore throat or combination thereof for longer than 48 hours

Secondary Outcome Measures

Name	Time	Method
Duration of respiratory tract infection	21 days	Time to CARIFS (Canadian Acute Respiratory Illness and Flu Scale) value 0
Number of workdays missed by parents	21 days
Antibiotic prescriptions	21 days	Percent
Number of unscheduled doctor visits	21 days
Number of days daycare/school missed	21 days
Time to resolution of individual CARIFS item	21	Days to the correspondent CARIFS item 0
Percent and duration of the use of over-the-counter medications	21day	Percent and duration of the use of over-the-counter medications
Complications of respiratory tract infections	21 days	Percent of otitis, sinusitis, bronchitis, pneumonia cases
25% and 50% decrease in the CARIFS score	21day	25% and 50% decrease in the CARIFS score
Severity of respiratory tract infection	21 days	a product of daily CARIFS times the duration of the disease
Hospitalization rate	21 days	Number of hospitalizations

Trial Locations

Locations (1)

Lviv City Children Hospital; 🇺🇦 Lviv, Ukraine