Probiotics in Prevention of Common Cold

Not Applicable

Completed

• Conditions: Viral Infections of the Upper Respiratory Tract

• Registration Number: NCT02013934
• Lead Sponsor: Probi AB

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Status Verified: 2013-12
• Study First Submitted: 2013-12-06
• Study First Submitted QC: 2013-12-11
• Study First Posted: 2013-12-17
• Primary Completion: 2016-05
• Study Completion: 2016-05-17
• Last Update Submitted: 2018-04-12
• Last Update Posted: 2018-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 899

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Incidence of common cold episodes	3 months

Trial Locations

Locations (1)

A&R; 🇩🇪 Berlin, Germany