Asthma Exacerbations, Gastrointestinal Diseases, Respiratory Tract Infections
Conditions
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.
Interventions
DIETARY_SUPPLEMENTProbiotic
OTHERPlacebo
Sponsors
University of Helsinki
Finnish Defense Forces
Finnish Institute for Health and Welfare
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Sick Days | Through study completion, an average of 4 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Number and Duration of Infection Episodes | Through study completion, an average of 4 months | 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 | Through study completion, an average of 4 months | Number of antibiotic treatments received were collected during the medical visits. |
| Number of Days Out of Service Due to an Infection | Through study completion, an average of 4 months | 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. |
Countries
Finland
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Probiotic Tablet (Military Recruits) Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks
Probiotic | 284 |
| Placebo Tablet (Military Recruits) Chrystalline celluloce 2 x 2, 3 weeks
Placebo | 284 |
| Probiotic Tablet (Reserve Officer Candidates) Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks
Probiotic | 204 |
| Placebo Tablet (Reserve Officer Candidates) Chrystalline celluloce 2 x 2, 3 weeks
Placebo | 211 |
| Total | 983 |
Baseline characteristics
| Characteristic | Total | Placebo Tablet (Military Recruits) | Probiotic Tablet (Reserve Officer Candidates) | Placebo Tablet (Reserve Officer Candidates) | Probiotic Tablet (Military Recruits) |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 983 Participants | 284 Participants | 204 Participants | 211 Participants | 284 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — | — | — |
| Region of Enrollment Finland | 983 participants | 284 participants | 204 participants | 211 participants | 284 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 983 Participants | 284 Participants | 204 Participants | 211 Participants | 284 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 284 | 0 / 284 | 0 / 204 | 0 / 211 |
| other Total, other adverse events | 0 / 284 | 0 / 284 | 0 / 204 | 0 / 211 |
| serious Total, serious adverse events | 0 / 284 | 0 / 284 | 0 / 204 | 0 / 211 |
Outcome results
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.
Time frame: Through study completion, an average of 4 months
Population: According to the study nurse, the file containing number of sick days data of this particular study is no more available.
p-value: <0.05Fisher Exact
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.
Time frame: Through study completion, an average of 4 months
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Probiotic Tablet (Military Recruits) | Number and Duration of Infection Episodes | 33 Episodes |
| Placebo Tablet (Military Recruits) | Number and Duration of Infection Episodes | 35 Episodes |
| Probiotic Tablet (Reserve Officer Candidates) | Number and Duration of Infection Episodes | 30 Episodes |
| Placebo Tablet (Reserve Officer Candidates) | Number and Duration of Infection Episodes | 29 Episodes |
p-value: <0.05Fisher Exact
Secondary
Number of Antibiotic Treatments Received
Number of antibiotic treatments received were collected during the medical visits.
Time frame: Through study completion, an average of 4 months
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Probiotic Tablet (Military Recruits) | Number of Antibiotic Treatments Received | 15 Treatments |
| Placebo Tablet (Military Recruits) | Number of Antibiotic Treatments Received | 23 Treatments |
| Probiotic Tablet (Reserve Officer Candidates) | Number of Antibiotic Treatments Received | 2 Treatments |
| Placebo Tablet (Reserve Officer Candidates) | Number of Antibiotic Treatments Received | 1 Treatments |
p-value: <0.05Fisher Exact
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.
Time frame: Through study completion, an average of 4 months
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Probiotic Tablet (Military Recruits) | Number of Days Out of Service Due to an Infection | 44 Days |
| Placebo Tablet (Military Recruits) | Number of Days Out of Service Due to an Infection | 41 Days |
| Probiotic Tablet (Reserve Officer Candidates) | Number of Days Out of Service Due to an Infection | 4 Days |
| Placebo Tablet (Reserve Officer Candidates) | Number of Days Out of Service Due to an Infection | 6 Days |
p-value: <0.05Fisher Exact