Viral Infections of the Upper Respiratory Tract Clinical Trial
Official title:
Benefit and Tolerability of a Probiotic Product in Subjects With Increased Susceptibility to Common Cold
| Verified date | December 2013 |
| Source | Probi AB |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The objective of this study is to assess the benefit and tolerability of a probiotic product in subjects with increased susceptibility to common cold.
| Status | Completed |
| Enrollment | 899 |
| Est. completion date | May 17, 2016 |
| Est. primary completion date | May 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | A&R | Berlin |
| Lead Sponsor | Collaborator |
|---|---|
| Probi AB |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Incidence of common cold episodes | 3 months |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT01085721 -
Comparison Between Dexchlorpheniramine and Dexchlorpheniramine/Pseudoephedrine/Guaifenesin in Respiratory Infections
|
Phase 3 |