Probiotics and Infections in Conscripts in Military Service

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Helsinki University
Finnish Defense Forces
National Institute for Health and Welfare, Finland
Information provided by (Responsible Party):
Anne pitkäranta, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01651195
First received: July 24, 2012
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Respiratory Tract Infections
Gastrointestinal Diseases
Asthma Exacerbations
Dietary Supplement: Probiotic
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Lactobacillus Rhamnosus GG in the Middle Ear After Randomized, Double-blind, Placebo-controlled Oral Administration

Resource links provided by NLM:


Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • The primary outcome measure is the recovery of Lactobacillus rhamnosus GG in the middle ear effusion and adenoid tonsil [ Time Frame: May 2009 ] [ Designated as safety issue: No ]

Estimated Enrollment: 900
Study Start Date: July 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01651195

Locations
Finland
The Finnish Defence Forces
Hamina, Finland
The Finnish Defence Forces
Upinniemi, Finland
Sponsors and Collaborators
Helsinki University Central Hospital
Helsinki University
Finnish Defense Forces
National Institute for Health and Welfare, Finland
  More Information

No publications provided

Responsible Party: Anne pitkäranta, Professor/Chief Physician at Hospital District of Helsinki and Uusimaa, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01651195     History of Changes
Other Study ID Numbers: 189/13/03/00/11
Study First Received: July 24, 2012
Last Updated: March 12, 2014
Health Authority: Finland: Ethics Committee

Additional relevant MeSH terms:
Communicable Diseases
Digestive System Diseases
Gastrointestinal Diseases
Infection
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 21, 2014