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Probiotics in Prevention of Common Cold

Primary Purpose

Viral Infections of the Upper Respiratory Tract

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Probiotic
Placebo
Sponsored by
Probi AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Viral Infections of the Upper Respiratory Tract

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • A&R

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Probiotics

Placebo

Arm Description

Dietary supplement

Dietary supplement

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of common cold episodes

Full Information

First Posted
December 6, 2013
Last Updated
April 12, 2018
Sponsor
Probi AB
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1. Study Identification

Unique Protocol Identification Number
NCT02013934
Brief Title
Probiotics in Prevention of Common Cold
Official Title
Benefit and Tolerability of a Probiotic Product in Subjects With Increased Susceptibility to Common Cold
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 17, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Probi AB

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Viral Infections of the Upper Respiratory Tract

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
899 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotics
Arm Type
Active Comparator
Arm Description
Dietary supplement
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Dietary supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Severity of cold symptoms
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Incidence of common cold episodes
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
A&R
City
Berlin
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
33296464
Citation
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.
Results Reference
derived

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Probiotics in Prevention of Common Cold

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