Probiotics and Infections in Conscripts in Military Service

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

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 Overview

• Status: Completed
• Conditions: Gastrointestinal Diseases; Respiratory Tract Infections; Asthma Exacerbations
• Intervention / Treatment: Other: Placebo; Dietary supplement: Probiotic

Detailed Description

Military conscripts are susceptible to respiratory and gastrointestinal tract infections. In previous studies probiotics have shown potency to reduce upper respiratory and gastrointestinal infections. 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 Type: Interventional
• Enrollment (Actual): 983
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Hamina, Finland
    • The Finnish Defence Forces
  • Upinniemi, Finland
    • The Finnish Defence Forces

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Probiotic tablet (military recruits); Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks	Other: Placebo; Dietary supplement: Probiotic
Placebo Comparator: Placebo tablet (military recruits); Crystalline cellulose 2 x 2, 3 weeks	Other: Placebo; Dietary supplement: Probiotic
Active Comparator: Probiotic tablet (reserve officer candidates); Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks	Other: Placebo; Dietary supplement: Probiotic
Placebo Comparator: Placebo tablet (reserve officer candidates); Crystalline cellulose 2 x 2, 3 weeks	Other: Placebo; Dietary supplement: Probiotic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Sick Days	The number of sick days with respiratory and gastrointestinal symptoms and symptom incidence. Other outcome measures were the number and duration of infection episodes, the number of antibiotic treatments received, and the number of days out of service due to an infection. Respiratory infection episodes and symptomatic days were counted by the basis of respiratory infection symptoms recorded into the symptom diary and from the medical visits to health care centers. If the conscript showed minimum of two RTI symptoms for a period of one day or one RTI symptom for a period of two days a RTI episode was considered to be present. Between two episodes a minimum of seven days of non-symptomatic period should be experienced if to be considered as two separate infections. If there were less non-symptomatic days, it was considered to be a continuation of the same infection episode. Symptomatic days were days when at least one symptom was experienced.	Through study completion, an average of 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and Duration of Infection Episodes	Respiratory infection episodes and symptomatic days were counted by the basis of respiratory infection symptoms recorded into the symptom diary and from the medical visits to health care centers.	Through study completion, an average of 4 months
Number of Antibiotic Treatments Received	Number of antibiotic treatments received were collected during the medical visits.	Through study completion, an average of 4 months
Number of Days Out of Service Due to an Infection	If the conscript showed minimum of two RTI symptoms for a period of one day or one RTI symptom for a period of two days a RTI episode was considered to be present. Between two episodes a minimum of seven days of non-symptomatic period should be experienced if to be considered as two separate infections. If there were less non-symptomatic days, it was considered to be a continuation of the same infection episode. Symptomatic days were days when at least one symptom was experienced. Gastrointestinal tract infection episodes and symptom days were calculated in the same fashion except 14 non symptomatic days should be in between the two to be considered as two different episodes.	Through study completion, an average of 4 months

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Collaborators: University of Helsinki; Finnish Institute for Health and Welfare; Finnish Defense Forces
• Investigators: Principal Investigator: Anne I Pitkäranta, md, Chief Physician

Publications and helpful links

General Publications

• Kalima K, Lehtoranta L, He L, Pitkaniemi J, Lundell R, Julkunen I, Roivainen M, Narkio M, Makela MJ, Siitonen S, Korpela R, Pitkaranta A. Probiotics and respiratory and gastrointestinal tract infections in Finnish military conscripts - a randomised placebo-controlled double-blinded study. Benef Microbes. 2016 Sep;7(4):463-71. doi: 10.3920/BM2015.0172. Epub 2016 Apr 6.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2012
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: July 24, 2012
• First Submitted That Met QC Criteria: July 24, 2012
• First Posted (Estimate): July 26, 2012

Study Record Updates

• Last Update Posted (Actual): June 14, 2021
• Last Update Submitted That Met QC Criteria: May 18, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Gastrointestinal Diseases; Digestive System Diseases; Respiratory Tract Infections
• Other Study ID Numbers: 189/13/03/00/11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No