Probiotics in Respiratory Tract Infections in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sergei V. Gerasimov, MD, PhD, Lviv National Medical University
ClinicalTrials.gov Identifier:
NCT01510938
First received: January 12, 2012
Last updated: December 25, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Infections, Respiratory Tract
Dietary Supplement: L. acidophilus DDS-1, B. lactis UABLA-12
Dietary Supplement: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Role of Probiotics in Prevention of Respiratory Tract Infections in Preschool and Primary School Children

Resource links provided by NLM:


Further study details as provided by Lviv National Medical University:

Primary Outcome Measures:
  • Incidence of respiratory tract infection episodes in a child [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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 Frame: 21 days ] [ Designated as safety issue: No ]
    Time to CARIFS (Canadian Acute Respiratory Illness and Flu Scale) value 0

  • Severity of respiratory tract infection [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    a product of daily CARIFS times the duration of the disease

  • Complications of respiratory tract infections [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    Percent of otitis, sinusitis, bronchitis, pneumonia cases

  • Antibiotic prescriptions [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    Percent

  • Hospitalization rate [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    Number of hospitalizations

  • Number of unscheduled doctor visits [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • Number of days daycare/school missed [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • Number of workdays missed by parents [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • Time to resolution of individual CARIFS item [ Time Frame: 21 ] [ Designated as safety issue: No ]
    Days to the correspondent CARIFS item 0

  • 25% and 50% decrease in the CARIFS score [ Time Frame: 21day ] [ Designated as safety issue: No ]
    25% and 50% decrease in the CARIFS score

  • Percent and duration of the use of over-the-counter medications [ Time Frame: 21day ] [ Designated as safety issue: No ]
    Percent and duration of the use of over-the-counter medications


Enrollment: 242
Study Start Date: January 2012
Study Completion Date: December 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: DDS-Junior

  Eligibility

Ages Eligible for Study:   3 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01510938

Locations
Ukraine
Lviv City Children Hospital
Lviv, Ukraine, 79059
Sponsors and Collaborators
Lviv National Medical University
Investigators
Principal Investigator: Sergei V Gerasimov, M.D., Ph.D. Lviv National Medical University
  More Information

No publications provided

Responsible Party: Sergei V. Gerasimov, MD, PhD, Associate Professor of Pediatrics, Lviv National Medical University
ClinicalTrials.gov Identifier: NCT01510938     History of Changes
Other Study ID Numbers: SG-11009
Study First Received: January 12, 2012
Last Updated: December 25, 2013
Health Authority: Ukraine: Ministry of Health

Keywords provided by Lviv National Medical University:
Children
Respiratory Tract Infections
Prevention

Additional relevant MeSH terms:
Communicable Diseases
Infection
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014