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Probiotics and Infections in Conscripts in Military Service

NCT01651195 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 983

Last updated 2021-06-14

Study results available
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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.

Conditions

  • Respiratory Tract Infections
  • Gastrointestinal Diseases
  • Asthma Exacerbations

Interventions

DIETARY_SUPPLEMENT

Probiotic

OTHER

Placebo

Sponsors & Collaborators

  • University of Helsinki

    collaborator OTHER

  • Finnish Defense Forces

    collaborator OTHER_GOV

  • Finnish Institute for Health and Welfare

    collaborator OTHER_GOV

  • Helsinki University Central Hospital

    lead OTHER

Principal Investigators

  • Anne I Pitkäranta, md · Chief Physician

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01651195 on ClinicalTrials.gov