Viral Infections of the Upper Respiratory Tract
Conditions
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.
Interventions
DIETARY_SUPPLEMENTProbiotic
DIETARY_SUPPLEMENTPlacebo
Sponsors
Probi AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of cold symptoms | 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
| Measure | Time frame |
|---|---|
| Incidence of common cold episodes | 3 months |
Countries
Germany
Outcome results
None listed