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Probiotics in Respiratory Tract Infections in Children

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ClinicalTrials.gov Identifier: NCT01510938
Recruitment Status : Completed
First Posted : January 18, 2012
Last Update Posted : December 30, 2013
Sponsor:
Information provided by (Responsible Party):
Sergei V. Gerasimov, MD, PhD, 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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 242 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Role of Probiotics in Prevention of Respiratory Tract Infections in Preschool and Primary School Children
Study Start Date : January 2012
Actual Primary Completion Date : May 2012
Actual Study Completion Date : December 2012

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 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




Primary Outcome Measures :
  1. Incidence of respiratory tract infection episodes in a child [ Time Frame: 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 :
  1. Duration of respiratory tract infection [ Time Frame: 21 days ]
    Time to CARIFS (Canadian Acute Respiratory Illness and Flu Scale) value 0

  2. Severity of respiratory tract infection [ Time Frame: 21 days ]
    a product of daily CARIFS times the duration of the disease

  3. Complications of respiratory tract infections [ Time Frame: 21 days ]
    Percent of otitis, sinusitis, bronchitis, pneumonia cases

  4. Antibiotic prescriptions [ Time Frame: 21 days ]
    Percent

  5. Hospitalization rate [ Time Frame: 21 days ]
    Number of hospitalizations

  6. Number of unscheduled doctor visits [ Time Frame: 21 days ]
  7. Number of days daycare/school missed [ Time Frame: 21 days ]
  8. Number of workdays missed by parents [ Time Frame: 21 days ]
  9. Time to resolution of individual CARIFS item [ Time Frame: 21 ]
    Days to the correspondent CARIFS item 0

  10. 25% and 50% decrease in the CARIFS score [ Time Frame: 21day ]
    25% and 50% decrease in the CARIFS score

  11. Percent and duration of the use of over-the-counter medications [ Time Frame: 21day ]
    Percent and duration of the use of over-the-counter medications



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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: January 18, 2012    Key Record Dates
Last Update Posted: December 30, 2013
Last Verified: December 2013

Keywords provided by Sergei V. Gerasimov, MD, PhD, Lviv National Medical University:
Children
Respiratory Tract Infections
Prevention

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