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Probiotics and Infections in Conscripts in Military Service

Primary Purpose

Respiratory Tract Infections, Gastrointestinal Diseases, Asthma Exacerbations

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Probiotic
Placebo
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Tract Infections

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Finnish Defence Forces
  • The Finnish Defence Forces

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

Probiotic tablet (military recruits)

Placebo tablet (military recruits)

Probiotic tablet (reserve officer candidates)

Placebo tablet (reserve officer candidates)

Arm Description

Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks

Crystalline cellulose 2 x 2, 3 weeks

Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks

Crystalline cellulose 2 x 2, 3 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Number of Antibiotic Treatments Received
Number of antibiotic treatments received were collected during the medical visits.
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.

Full Information

First Posted
July 24, 2012
Last Updated
May 18, 2021
Sponsor
Helsinki University Central Hospital
Collaborators
University of Helsinki, Finnish Defense Forces, Finnish Institute for Health and Welfare
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1. Study Identification

Unique Protocol Identification Number
NCT01651195
Brief Title
Probiotics and Infections in Conscripts in Military Service
Official Title
Probiotic and Respiratory and Gastrointestinal Tract Infections in Finnish Military Conscripts - a Randomized and Placebo-controlled Double-blinded Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
July 2012 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
Collaborators
University of Helsinki, Finnish Defense Forces, Finnish Institute for Health and Welfare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Tract Infections, Gastrointestinal Diseases, Asthma Exacerbations

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
983 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotic tablet (military recruits)
Arm Type
Active Comparator
Arm Description
Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks
Arm Title
Placebo tablet (military recruits)
Arm Type
Placebo Comparator
Arm Description
Crystalline cellulose 2 x 2, 3 weeks
Arm Title
Probiotic tablet (reserve officer candidates)
Arm Type
Active Comparator
Arm Description
Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks
Arm Title
Placebo tablet (reserve officer candidates)
Arm Type
Placebo Comparator
Arm Description
Crystalline cellulose 2 x 2, 3 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number of Sick Days
Description
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.
Time Frame
Through study completion, an average of 4 months
Secondary Outcome Measure Information:
Title
Number and Duration of Infection Episodes
Description
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.
Time Frame
Through study completion, an average of 4 months
Title
Number of Antibiotic Treatments Received
Description
Number of antibiotic treatments received were collected during the medical visits.
Time Frame
Through study completion, an average of 4 months
Title
Number of Days Out of Service Due to an Infection
Description
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.
Time Frame
Through study completion, an average of 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne I Pitkäranta, md
Organizational Affiliation
Chief Physician
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Finnish Defence Forces
City
Hamina
Country
Finland
Facility Name
The Finnish Defence Forces
City
Upinniemi
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27048835
Citation
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.
Results Reference
derived

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Probiotics and Infections in Conscripts in Military Service

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