Probiotics in Prevention of Common Cold

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

Study Overview

• Status: Completed
• Conditions: Viral Infections of the Upper Respiratory Tract
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Probiotic

• Study Type: Interventional
• Enrollment (Actual): 899
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • A&R

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Probiotics; Dietary supplement	Dietary supplement: Probiotic
Placebo Comparator: Placebo; Dietary supplement	Dietary supplement: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Incidence of common cold episodes	3 months

Collaborators and Investigators

• Sponsor: Probi AB

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 17, 2016

Study Registration Dates

• First Submitted: December 6, 2013
• First Submitted That Met QC Criteria: December 11, 2013
• First Posted (Estimate): December 17, 2013

Study Record Updates

• Last Update Posted (Actual): April 17, 2018
• Last Update Submitted That Met QC Criteria: April 12, 2018
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Picornaviridae Infections; Virus Diseases; Common Cold
• Other Study ID Numbers: PAB/011013