Probiotics and Infections in Conscripts in Military Service

Helsinki University Central Hospital (HUCH)

Status: Completed

Conditions: Gastrointestinal Diseases; Asthma Exacerbations; Respiratory Tract Infections

Treatments: Other: Placebo; Dietary Supplement: Probiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT01651195

189/13/03/00/11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 983 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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983 participants in 4 patient groups, including a placebo group

Probiotic tablet (military recruits)

Active Comparator group

Description:

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

Treatment:

Other: Placebo

Dietary Supplement: Probiotic

Placebo tablet (military recruits)

Placebo Comparator group

Description:

Crystalline cellulose 2 x 2, 3 weeks

Treatment:

Other: Placebo

Dietary Supplement: Probiotic

Probiotic tablet (reserve officer candidates)

Active Comparator group

Description:

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

Treatment:

Other: Placebo

Dietary Supplement: Probiotic

Placebo tablet (reserve officer candidates)

Placebo Comparator group

Description:

Crystalline cellulose 2 x 2, 3 weeks

Treatment:

Other: Placebo

Dietary Supplement: Probiotic