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Completed

NCT Number: NCT01510938

Probiotics in Respiratory Tract Infections in Children

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

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Key information

Conditions

Infections, Respiratory Tract Infections Respiratory Tract Diseases Respiratory Tract Infections

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Lviv City Children Hospital

Lviv, Lviv Oblast, 79059, Ukraine

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

L. acidophilus DDS-1, B. lactis UABLA-12

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Lviv National Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 18, 2012
Registry last updated
Dec 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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