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N/A N=983 Randomized Quadruple-blind Prevention

Probiotics and Infections in Conscripts in Military Service

Respiratory Tract Infections · Gastrointestinal Diseases · Asthma Exacerbations

Enrolled (actual)
983
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Number of Sick Days — p=< 0.05

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Probiotic (Dietary_supplement); Placebo (Other)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Helsinki University Central Hospital
Primary completion
Jun 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Sick Days
< 0.05 sig
SECONDARY
Number and Duration of Infection Episodes
33; 35; 30; 29 < 0.05 sig
SECONDARY
Number of Antibiotic Treatments Received
15; 23; 2; 1 < 0.05 sig
SECONDARY
Number of Days Out of Service Due to an Infection
44; 41; 4; 6 < 0.05 sig

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.

Eligibility Criteria

Inclusion Criteria

  • Healthy adults attending military service in July 2012 and healthy adults attending reserve office school in October 2012

Exclusion Criteria

  • Regular use of oral corticosteroids
  • Regular consumption (over 3 times a week) of probiotic bacteria containing products 3 weeks before intervention
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01651195). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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