Probiotics in Respiratory Tract Infections in Children

NCT01510938 | Completed Phase 2 DMC

• 1 other identifier: SG-11009
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

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

Conditions

Infections, Respiratory Tract

Keywords

Children; Respiratory Tract Infections; Prevention

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• Duration of respiratory tract infection

  21 days

• Severity of respiratory tract infection

  21 days

• Complications of respiratory tract infections

  21 days

• Antibiotic prescriptions

  21 days

• Hospitalization rate

  21 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Probiotic

EXPERIMENTAL

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

Interventions

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.

Also known as: DDS-Junior

Probiotic

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.

Also known as: Rice maltodextrin

Placebo

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 3-12 yrs
• At least one episode of respiratory tract infection in the previous epidemiological season
• Direct telephone access available
• Informed consent signed

You may not qualify if:

• 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

Sponsors & Collaborators

• Lviv National Medical University: lead

Study Sites (1)

Lviv City Children Hospital

Lviv, Lviv Oblast, 79059, Ukraine

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Sergei V Gerasimov, M.D., Ph.D.

  Lviv National Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: January 12, 2012
• First Posted: January 18, 2012
• Study Start: January 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 30, 2013

Record last verified: 2013-12

Locations

UA (1)