Probiotics in Prevention of Common Cold

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Probi AB
Sponsor:
Information provided by (Responsible Party):
Probi AB
ClinicalTrials.gov Identifier:
NCT02013934
First received: December 6, 2013
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

The objective of this study is to assess the benefit and tolerability of a probiotic product in subjects with increased susceptibility to common cold.


Condition Intervention Phase
Viral Infections of the Upper Respiratory Tract
Dietary Supplement: Probiotic
Dietary Supplement: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Benefit and Tolerability of a Probiotic Product in Subjects With Increased Susceptibility to Common Cold

Resource links provided by NLM:


Further study details as provided by Probi AB:

Primary Outcome Measures:
  • Severity of cold symptoms [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Severity of cold symptoms based on the questionnaire WURSS-21 during the cold episodes throughout the study period, in comparison between verum and placebo group


Secondary Outcome Measures:
  • Incidence of common cold episodes [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 312
Study Start Date: October 2013
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Probiotics
Dietary supplement
Dietary Supplement: Probiotic
Placebo Comparator: Placebo
Dietary supplement
Dietary Supplement: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • males and females
  • age 18-70 years
  • increased risk for common cold (at least 4 episodes within 12 months)
  • commitment to adhere to former diet and physical activity
  • commitment not to use any products that may influence the study outcome (e.g. immune suppressants/immune stimulants, including paramedication such as e.g. Echinacea, analgesics/anti-rheumatics, anti-phlogistics, antitussives/expectorants, influenza remedies, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, probiotics) during the study (except for rescue medication, see 7.5)
  • women of child-bearing potential have to agree to use appropriate birth control methods Written consent of the subject to participate is a prerequisite for study participation.

Exclusion Criteria:

  • acute / chronic upper / lower airways disease
  • chronic cough of any origin
  • any allergic reaction that may influence the study outcome (e.g. acute/chronic rhinitis)
  • history of nasal reconstructive surgery
  • presence of nasal ulcers or nasal polyps
  • severe nasal septum deviation or other condition that could cause nasal obstruction
  • congenital or acquired immunodeficiency disease (e.g. HIV infection)
  • Bechterew's disease
  • body temperature above 37.5°C
  • suspected swine flu or influenza
  • vaccination with a vaccine containing an adjuvant within 3 months prior to study start and during the study
  • vaccination with a vaccine not containing an adjuvant within 6 weeks prior to study start and during the study
  • stomach/gastrointestinal diseases
  • serious organ or systemic diseases
  • sleep disorder
  • psychiatric disorders
  • known sensitivity to the ingredients of the investigational product
  • regular intake of products that may influence the study outcome (e.g. immune suppressants/immune stimulants, including paramedication such as e.g. Echinacea, analgesics/anti-rheumatics, anti-phlogistics, antitussives/expectorants, influenza remedies, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, probiotics) within the last 4 weeks prior to study start
  • habitual usage of nasal drops/spray
  • pregnancy or nursing
  • alcohol / drug abuse
  • simultaneous participation in another clinical trial or participation in a clinical trial within the last 30 days
  • insufficient compliance
  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: NCT02013934

Contacts
Contact: Irini Lazou Ahrén, PhD +46 46 286 89 22 ila@probi.se

Locations
Germany
A&R Recruiting
Berlin, Germany
Contact: Marco Schaudt       mschaudt@analyze-realize.com   
Sponsors and Collaborators
Probi AB
  More Information

No publications provided

Responsible Party: Probi AB
ClinicalTrials.gov Identifier: NCT02013934     History of Changes
Other Study ID Numbers: PAB/011013
Study First Received: December 6, 2013
Last Updated: December 11, 2013
Health Authority: Germany: Charité - Universitätsmedizin Berlin Ethikkommission

Additional relevant MeSH terms:
Common Cold
Virus Diseases
Picornaviridae Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 22, 2014