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Completed

NCT Number: NCT01651195

Probiotics and Infections in Conscripts in Military Service

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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Key information

Conditions

Respiratory Tract Infections Asthma Exacerbations Digestive System Diseases Gastrointestinal Diseases Infections Respiratory Tract Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Finnish Defence Forces, Hamina, Finland

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic

Dietary Supplement

Placebo

Other

Primary outcomes

  1. Number of Sick Days

    Time frame: 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 outcomes

  1. Number and Duration of Infection Episodes

    Time frame: 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.

  2. Number of Antibiotic Treatments Received

    Time frame: Through study completion, an average of 4 months

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

  3. Number of Days Out of Service Due to an Infection

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • Finnish Defense Forces
  • Finnish Institute for Health and Welfare
  • University of Helsinki

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jul 26, 2012
Registry last updated
Jun 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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