Probiotics in Respiratory Tract Infections in Children

Lviv National Medical University (LNMU)

Status and phase: Completed; Phase 2

Conditions: Infections, Respiratory Tract

Treatments: Dietary Supplement: Placebo; Dietary Supplement: L. acidophilus DDS-1, B. lactis UABLA-12

Study type: Interventional

Funder types: Other

Identifiers

NCT01510938

SG-11009

Details and patient eligibility

About

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

Enrollment: 242 patients

Sex: All

Ages: 3 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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242 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo

Probiotic

Experimental group

Description:

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.

Treatment:

Dietary Supplement: L. acidophilus DDS-1, B. lactis UABLA-12