Probiotics in Prevention of Common Cold

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

Official Title
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Benefit and Tolerability of a Probiotic Product in Subjects With Increased Susceptibility to Common Cold

Conditions
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Viral Infections of the Upper Respiratory Tract

Intervention / Treatment
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* Dietary Supplement: Probiotic
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Probiotics<br>Dietary supplement | Dietary Supplement: Probiotic<br> <br> |
| Placebo Comparator: Placebo<br>Dietary supplement | Dietary Supplement: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of cold symptoms | 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 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of common cold episodes |  | 3 months |