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Probiotics in Respiratory Tract Infections in Children

Primary Purpose

Infections, Respiratory Tract

Status
Completed
Phase
Phase 2
Locations
Ukraine
Study Type
Interventional
Intervention
L. acidophilus DDS-1, B. lactis UABLA-12
Placebo
Sponsored by
Lviv National Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infections, Respiratory Tract focused on measuring Children, Respiratory Tract Infections, Prevention

Eligibility Criteria

3 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Lviv City Children Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Probiotic

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 12, 2012
Last Updated
December 25, 2013
Sponsor
Lviv National Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01510938
Brief Title
Probiotics in Respiratory Tract Infections in Children
Official Title
Role of Probiotics in Prevention of Respiratory Tract Infections in Preschool and Primary School Children
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lviv National Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Respiratory Tract
Keywords
Children, Respiratory Tract Infections, Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
242 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Probiotic
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
L. acidophilus DDS-1, B. lactis UABLA-12
Other Intervention Name(s)
DDS-Junior
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
Rice maltodextrin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of respiratory tract infection episodes in a child
Description
An episode will be defined as display of fever, cough, rhinitis, and sore throat or combination thereof for longer than 48 hours
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Duration of respiratory tract infection
Description
Time to CARIFS (Canadian Acute Respiratory Illness and Flu Scale) value 0
Time Frame
21 days
Title
Severity of respiratory tract infection
Description
a product of daily CARIFS times the duration of the disease
Time Frame
21 days
Title
Complications of respiratory tract infections
Description
Percent of otitis, sinusitis, bronchitis, pneumonia cases
Time Frame
21 days
Title
Antibiotic prescriptions
Description
Percent
Time Frame
21 days
Title
Hospitalization rate
Description
Number of hospitalizations
Time Frame
21 days
Title
Number of unscheduled doctor visits
Time Frame
21 days
Title
Number of days daycare/school missed
Time Frame
21 days
Title
Number of workdays missed by parents
Time Frame
21 days
Title
Time to resolution of individual CARIFS item
Description
Days to the correspondent CARIFS item 0
Time Frame
21
Title
25% and 50% decrease in the CARIFS score
Description
25% and 50% decrease in the CARIFS score
Time Frame
21day
Title
Percent and duration of the use of over-the-counter medications
Description
Percent and duration of the use of over-the-counter medications
Time Frame
21day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergei V Gerasimov, M.D., Ph.D.
Organizational Affiliation
Lviv National Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lviv City Children Hospital
City
Lviv
ZIP/Postal Code
79059
Country
Ukraine

12. IPD Sharing Statement

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