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Probiotics in Prevention of Common Cold

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02013934
Recruitment Status : Unknown
Verified December 2013 by Probi AB.
Recruitment status was:  Recruiting
First Posted : December 17, 2013
Last Update Posted : December 17, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Viral Infections of the Upper Respiratory Tract Dietary Supplement: Probiotic Dietary Supplement: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 312 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Benefit and Tolerability of a Probiotic Product in Subjects With Increased Susceptibility to Common Cold
Study Start Date : October 2013
Estimated Primary Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Common Cold
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Probiotics
Dietary supplement
Dietary Supplement: Probiotic
Placebo Comparator: Placebo
Dietary supplement
Dietary Supplement: Placebo


Outcome Measures

Primary Outcome Measures :
  1. Severity of cold symptoms [ Time Frame: 3 months ]
    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 :
  1. Incidence of common cold episodes [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): 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

Responsible Party: Probi AB
ClinicalTrials.gov Identifier: NCT02013934     History of Changes
Other Study ID Numbers: PAB/011013
First Posted: December 17, 2013    Key Record Dates
Last Update Posted: December 17, 2013
Last Verified: December 2013

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