Probiotics in Respiratory Tract Infections in Children

Infections, Respiratory Tract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01510938
• Other study ID #: SG-11009
• 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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infections, Respiratory Tract
• Respiratory Tract Infections

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