Probiotics in Respiratory Tract Infections in Children

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

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

Study Overview

• Status: Completed
• Conditions: Infections, Respiratory Tract
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: L. acidophilus DDS-1, B. lactis UABLA-12

• Study Type: Interventional
• Enrollment (Actual): 242
• Phase: Phase 2

Contacts and Locations

Study Locations

• Ukraine
  • Lviv, Ukraine, 79059
    • Lviv City Children Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 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.	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
EXPERIMENTAL: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Lviv National Medical University
• Investigators: Principal Investigator: Sergei V Gerasimov, M.D., Ph.D., Lviv National Medical University

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ACTUAL): May 1, 2012
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: January 12, 2012
• First Submitted That Met QC Criteria: January 17, 2012
• First Posted (ESTIMATE): January 18, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): December 30, 2013
• Last Update Submitted That Met QC Criteria: December 25, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Children; Prevention; Respiratory Tract Infections
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID Numbers: SG-11009