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Probiotics and Infections in Conscripts in Military Service

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ClinicalTrials.gov Identifier: NCT01651195
Recruitment Status : Unknown
Verified January 2016 by Anne pitkäranta, Helsinki University Central Hospital.
Recruitment status was:  Active, not recruiting
First Posted : July 26, 2012
Last Update Posted : January 8, 2016
Sponsor:
Collaborators:
University of Helsinki
Finnish Defense Forces
Finnish Institute for Health and Welfare
Information provided by (Responsible Party):
Anne pitkäranta, Helsinki University Central Hospital

Study Description
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Brief Summary:
The purpose of this study is to evaluate the effect of regular consumption of probiotic tablets in preventing illnesses in Finnish healthy adults attending military service.

Condition or disease Intervention/treatment Phase
Respiratory Tract Infections Gastrointestinal Diseases Asthma Exacerbations Dietary Supplement: Probiotic Other: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Probiotic and Respiratory and Gastrointestinal Tract Infections in Finnish Military Conscripts - a Randomized and Placebo-controlled Double-blinded Study
Study Start Date : July 2012
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2016
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Probiotic tablet
Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks
 Dietary Supplement: Probiotic
Placebo Comparator: Placebo tablet
Chrystalline celluloce 2 x 2, 3 weeks
 Other: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. The primary outcome measure is to investigate whether probiotic combination of Lactobacillus rhamnosus GG and Bifidobacterium lactose BB12 would decrease respirvatory and gastrointestinal infection in conscripts attending military service in Fnland [ Time Frame: June 2016 ]

Secondary Outcome Measures :
  1. To study the role of probiotic combination on seasonal occurrence of infections in two differ conscript groups [ Time Frame: June 2016 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01651195


Locations
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Finland
The Finnish Defence Forces
Hamina, Finland
The Finnish Defence Forces
Upinniemi, Finland
Sponsors and Collaborators
Helsinki University Central Hospital
University of Helsinki
Finnish Defense Forces
Finnish Institute for Health and Welfare
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Anne pitkäranta, Professor/Chief Physician at Hospital District of Helsinki and Uusimaa, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01651195    
Other Study ID Numbers: 189/13/03/00/11
First Posted: July 26, 2012    Key Record Dates
Last Update Posted: January 8, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Tract Infections
 Gastrointestinal Diseases
Digestive System Diseases
Respiratory Tract Diseases