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OpenTrials
Completed

NCT Number: NCT02013934

Probiotics in Prevention of Common Cold

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

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Key information

Conditions

Viral Infections of the Upper Respiratory Tract

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

A&R

Berlin, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. Severity of cold symptoms

    Time frame: 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 outcomes

  1. Incidence of common cold episodes

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Probi AB

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 17, 2013
Registry last updated
Apr 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.