Lactobacillus GG in prevention of gastrointestinal and respiratory tract infections in healthy children: Randomised, double-blind, placebo-controlled study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16959643

Enrollment

300

Registered

2008-04-11

Start date

2007-11-20

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal and respiratory tract infections in children Infections and Infestations Nosocomial condition

Interventions

All children at kindergarten whose parents have signed an inform consent, would be randomly assigned into one of two following groups: 1.Group A will receive LGG at a dose 10^10 CFU per day in fermen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All children attending day care at two kindergartens located in the Zagreb city centre with approximately 300 children, age from 12 months to 7 years.

Exclusion criteria

Exclusion criteria: 1. Immunodeficiency 2. Cow's milk allergy (probiotics will be given in fermented cow's milk product) 3. Receiving infant formula containing probiotics and/or prebiotics at the time of enrolment 4. Receiving probiotic and/or prebiotic products prior to enrolment (7 days prior to hospitalization) 5. Neoplasms 6. Chronic disorders

Design outcomes

Primary

Measure	Time frame
The following will be assessed after 3 months of intervention: 1. Rate of gastrointestinal tract infections including diarrhea (defined as 3 or more loose or watery stools in 24 hours) and vomiting 2. Rate of upper respiratory tract infections including rhinitis, pharyngitis, otitis, common cold and sinusitis 3. Rate of lower respiratory tract infections including pneumonia, bronchitis and bronciolitis (diagnosis by physician) 4. Duration of gastrointestinal and respiratory tract infections	—

Measure

Time frame

The following will be assessed after 3 months of intervention: 1. Rate of gastrointestinal tract infections including diarrhea (defined as 3 or more loose or watery stools in 24 hours) and vomiting 2. Rate of upper respiratory tract infections including rhinitis, pharyngitis, otitis, common cold and sinusitis 3. Rate of lower respiratory tract infections including pneumonia, bronchitis and bronciolitis (diagnosis by physician) 4. Duration of gastrointestinal and respiratory tract infections

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Secondary

Measure	Time frame
The following will be assessed after 3 months of interventions: 1. In participants with gastrointestinal tract infections: 1.1. Duration of symptoms 1.2. Number of stools or vomiting episodes 1.3. Number of infections with determined infective cause: Nature of infective etiology 2. In participants with respiratory tract infections: 2.1. Duration of symptoms (cough, fever) 2.2. Severity of infection (mild, moderate, severe) 2.3. Need for antibiotics 2.4. Number of infections with determined infective cause: Nature of infective etiology	—

Measure

Time frame

The following will be assessed after 3 months of interventions: 1. In participants with gastrointestinal tract infections: 1.1. Duration of symptoms 1.2. Number of stools or vomiting episodes 1.3. Number of infections with determined infective cause: Nature of infective etiology 2. In participants with respiratory tract infections: 2.1. Duration of symptoms (cough, fever) 2.2. Severity of infection (mild, moderate, severe) 2.3. Need for antibiotics 2.4. Number of infections with determined infective cause: Nature of infective etiology

—

Countries

Croatia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026