CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 983 enrolled
Drug / intervention
Probiotic +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01651195
NCT01651195N/ACompleted

Probiotic and Respiratory and Gastrointestinal Tract Infections in Finnish Military Conscripts - a Randomized and Placebo-controlled Double-blinded Study

Helsinki University Central Hospital·interventional·Posted Jul 26, 2012·Updated Jun 14, 2021

In Brief

A clinical study evaluating Probiotic and Placebo for Respiratory Tract Infections and 2 related conditions. Completed, enrolled 983 participants across 2 sites.

Detailed Summary

The aim was to study whether probiotic intervention has an impact on seasonal occurrence of upper respiratory and gastrointestinal infections in two different conscript groups. In a randomised, double-blinded, placebo controlled study a total of 983 healthy adults were enrolled from two intakes of conscripts. Conscripts were randomised to receive either a probiotic combination of Lactobacillus rhamnosus GG (LGG) and Bifidobacterium animalis ssp. lactis BB12 (BB12) or a control chewing tablet twice daily for 150 days (recruits) or for 90 days (reserve officer candidates). Clinical examinations were carried out and daily symptom diaries were collected. Outcome measures were the number of days with respiratory and gastrointestinal symptoms and symptom incidence, number and duration of infection episodes, number of antibiotic treatments received and number of days out of service because of the infection. Statistically no significant differences were found between the intervention groups either in the risk of symptom incidence or duration. However, probiotic intervention was associated with reduction of specific respiratory infection symptoms in military recruits, but not in reserve officer candidates. Probiotics did not significantly reduce overall respiratory and gastrointestinal infection morbidity.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFinland

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 26, 2012
Enrollment StartJul 1, 2012
Primary CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 13.9 years ago

Interventions

Probioticdietary

Placeboother