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| Name | Class |
|---|---|
| University of Helsinki | OTHER |
| Finnish Defense Forces | OTHER_GOV |
| Finnish Institute for Health and Welfare | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic tablet (military recruits) | Active Comparator | Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks |
|
| Placebo tablet (military recruits) | Placebo Comparator | Crystalline cellulose 2 x 2, 3 weeks |
|
| Probiotic tablet (reserve officer candidates) | Active Comparator | Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks |
|
| Placebo tablet (reserve officer candidates) | Placebo Comparator | Crystalline cellulose 2 x 2, 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne I Pitkäranta, md | Chief Physician | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Finnish Defence Forces | Hamina | Finland | ||||
| The Finnish Defence Forces |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27048835 | Derived | 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. |
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Sample size was calculated on the assumption that the use of probiotic would result in a 17% reduction in the number of sick days estimated that, with a power of 85% and at a significance level of 0.05 (Power 0.85, ß=0.15000 and α=0.05), we needed 300 conscripts per group to show a 17% difference between the groups. Each conscript was randomly allocated to the probiotic or the control group according to a computer generated, 8-blocked randomization list.
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| ID | Title | Description |
|---|---|---|
| FG000 | Probiotic Tablet (Military Recruits) | Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks Probiotic |
| FG001 | Placebo Tablet (Military Recruits) | Chrystalline celluloce 2 x 2, 3 weeks Placebo |
| FG002 | Probiotic Tablet (Reserve Officer Candidates) | Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks Probiotic |
| FG003 | Placebo Tablet (Reserve Officer Candidates) | Chrystalline celluloce 2 x 2, 3 weeks Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Probiotic Tablet (Military Recruits) | Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks Probiotic |
| BG001 | Placebo Tablet (Military Recruits) | Chrystalline celluloce 2 x 2, 3 weeks Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | According to the study nurse, the file containing number of sick days data of this particular study is no more available. | Posted | Through study completion, an average of 4 months | Days | Days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Probiotic Tablet (Military Recruits) | Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks Probiotic |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Anne Pitkäranta | Helsinki University Central Hospital | +358406430511 | anne.pitkaranta@hus.fi |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Placebo | Other |
|
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 |
| Upinniemi |
| Finland |
| BG002 | Probiotic Tablet (Reserve Officer Candidates) | Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks Probiotic |
| BG003 | Placebo Tablet (Reserve Officer Candidates) | Chrystalline celluloce 2 x 2, 3 weeks Placebo |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Title |
|---|
| Description |
|---|
| OG000 | Probiotic Tablet (Military Recruits) | Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks |
| OG001 | Placebo Tablet (Military Recruits) | Crystalline cellulose 2 x 2, 3 weeks |
| OG002 | Probiotic Tablet (Reserve Officer Candidates) | Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks |
| OG003 | Placebo Tablet (Reserve Officer Candidates) | Crystalline cellulose 2 x 2, 3 weeks |
|
|
| Secondary | 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. | Posted | Count of Units | Episodes | Through study completion, an average of 4 months | Episodes | Episodes |
|
|
|
|
| Secondary | Number of Antibiotic Treatments Received | Number of antibiotic treatments received were collected during the medical visits. | Posted | Count of Units | Treatments | Through study completion, an average of 4 months | Treatments | Treatments |
|
|
|
|
| Secondary | 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. | Posted | Count of Units | Days | Through study completion, an average of 4 months | Days | Days |
|
|
|
|
| 0 |
| 284 |
| 0 |
| 284 |
| 0 |
| 284 |
| EG001 | Placebo Tablet (Military Recruits) | Chrystalline celluloce 2 x 2, 3 weeks Placebo | 0 | 284 | 0 | 284 | 0 | 284 |
| EG002 | Probiotic Tablet (Reserve Officer Candidates) | Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks Probiotic | 0 | 204 | 0 | 204 | 0 | 204 |
| EG003 | Placebo Tablet (Reserve Officer Candidates) | Chrystalline celluloce 2 x 2, 3 weeks Placebo | 0 | 211 | 0 | 211 | 0 | 211 |
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| D019602 |
| Food and Beverages |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Days |
|