Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
899 participants
INTERVENTIONAL
2013-10-31
2016-05-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Probiotics
Dietary supplement
Probiotic
Placebo
Dietary supplement
Placebo
Interventions
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Probiotic
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
Yes
Sponsors
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Probi AB
INDUSTRY
Responsible Party
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Locations
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A&R
Berlin, , Germany
Countries
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References
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Ahren IL, Hillman M, Nordstrom EA, Larsson N, Niskanen TM. Fewer Community-Acquired Colds with Daily Consumption of Lactiplantibacillus plantarum HEAL9 and Lacticaseibacillus paracasei 8700:2. A Randomized, Placebo-Controlled Clinical Trial. J Nutr. 2021 Jan 4;151(1):214-222. doi: 10.1093/jn/nxaa353.
Other Identifiers
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PAB/011013
Identifier Type: -
Identifier Source: org_study_id
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