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ClinicalTrials.gov Identifier: NCT02013934
Verified December 2013 by Probi AB. Recruitment status was: Recruiting
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Ages Eligible for Study:
18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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)
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
serious organ or systemic diseases
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