Probiotics and Infections in Conscripts in Military Service

NCT01651195 | Completed Results

• 1 other identifier: 189/13/03/00/11
• Study Type: interventional
• Target: 983
• Locations: 1 country
• Sites: 2

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.

Conditions

Respiratory Tract Infections; Gastrointestinal Diseases; Asthma Exacerbations

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Number and Duration of Infection Episodes

  Through study completion, an average of 4 months

• Number of Antibiotic Treatments Received

  Through study completion, an average of 4 months

• Number of Days Out of Service Due to an Infection

  Through study completion, an average of 4 months

Study Arms (4)

Probiotic tablet (military recruits)

ACTIVE COMPARATOR

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

Dietary Supplement: Probiotic; Other: Placebo

Placebo tablet (military recruits)

PLACEBO COMPARATOR

Crystalline cellulose 2 x 2, 3 weeks

Dietary Supplement: Probiotic; Other: Placebo

Probiotic tablet (reserve officer candidates)

ACTIVE COMPARATOR

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

Dietary Supplement: Probiotic; Other: Placebo

Placebo tablet (reserve officer candidates)

PLACEBO COMPARATOR

Crystalline cellulose 2 x 2, 3 weeks

Dietary Supplement: Probiotic; Other: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

Placebo tablet (military recruits); Placebo tablet (reserve officer candidates); Probiotic tablet (military recruits); Probiotic tablet (reserve officer candidates)

Placebo OTHER

Placebo tablet (military recruits); Placebo tablet (reserve officer candidates); Probiotic tablet (military recruits); Probiotic tablet (reserve officer candidates)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults attending military service in July 2012 and healthy adults attending reserve office school in October 2012

You may not qualify if:

• Regular use of oral corticosteroids
• Regular consumption (over 3 times a week) of probiotic bacteria containing products 3 weeks before intervention

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• University of Helsinki: collaborator
• Finnish Defense Forces: collaborator
• Finnish Institute for Health and Welfare: collaborator

Study Sites (2)

The Finnish Defence Forces

Hamina, Finland

Location

The Finnish Defence Forces

Upinniemi, Finland

Location

Related Publications (1)

• 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.

  PMID: 27048835 DERIVED

MeSH Terms

Conditions

Respiratory Tract Infections; Gastrointestinal Diseases

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Prof. Anne Pitkäranta
• Organization: Helsinki University Central Hospital

anne.pitkaranta@hus.fi

+358406430511

Study Officials

• Anne I Pitkäranta, md

  Chief Physician

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor/Chief Physician at Hospital District of Helsinki and Uusimaa

Study Record Dates

• First Submitted: July 24, 2012
• First Posted: July 26, 2012
• Study Start: July 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 14, 2021
• Results First Posted: June 14, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

FI (2)