Effect of Probiotic on Rhinovirus Induced Colds

Not Applicable

Completed

• Conditions: Common Cold
• Interventions: Other: sucrose; Biological: Bifidobacterium animalis subsp. lactis Bl-04

• Registration Number: NCT02679807
• Lead Sponsor: University of Virginia

Brief Summary

This is a randomized, double-blind placebo controlled trial to evaluate the effect of a probiotic (Bl-04) on the occurrence of rhinovirus-associated common cold illness in the experimental rhinovirus challenge model. A previous study documented that Bl-04 has significant effects on the innate immune response in the nose and this study will be powered to assess whether these effects translate into a demonstrable clinical benefit. Volunteers will be given Bl-04 or placebo for 28 days then challenged with rhinovirus. The primary analysis will be on the proportion of volunteers who develop a rhinovirus associated illness in the two treatment groups.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-08
• Study First Submitted QC: 2016-02-08
• Study First Posted: 2016-02-10
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Status Verified: 2020-03
• Results First Submitted: 2020-03-03
• Results First Submitted QC: 2020-03-03
• Last Update Submitted: 2020-03-16
• Results First Posted: 2020-03-17
• Last Update Posted: 2020-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 380

Inclusion Criteria

INCLUSION CRITERIA AT ENROLLMENT:

• Subject must be 18-60 years of age.
• Subject must read and sign a copy of the approved Consent Form
• Subject must have a serum neutralizing antibody titer of less than or equal to 1:4 to rhinovirus type 39

INCLUSION CRITERIA AT DAY -28

• Female subjects must be using an effective birth control method.

INCLUSION CRITERIA AT CHALLENGE:

• Female subjects must be using an effective birth control method.

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Exclusion Criteria

• Antibiotic use within 3 months prior to day -28

  • Female subjects with a positive urine pregnancy screen
  • History of use of probiotics in the preceding two weeks
  • Current cancer diagnosis or immunosuppressive therapy in the last 6 months
  • Any clinically significant abnormalities of the upper respiratory tract
  • Any clinically significant acute or chronic respiratory illness
  • Any clinically significant bleeding tendency by history
  • Hypertension that requires treatment with antihypertensive medications
  • History of angina or other clinically significant cardiac disease
  • Any medical condition that in the opinion of the Principal Investigator is cause for exclusion from the study
  • History of regular use (more than 3 days in 7) of tobacco products within the preceding two weeks
  • History of drug or alcohol abuse in the 6 months preceding the study

EXCLUSION CRITERIA AT CHALLENGE:

• Any upper respiratory infection or allergic rhinitis in the two weeks prior to the challenge
• Female subjects with positive pregnancy screen prior to challenge
• Any medical condition that in the opinion of the Principal Investigator is cause for exclusion from the study
• Use of any anti-inflammatory (steroids or NSAIDs) or cough/cold or allergy preparation in the two weeks prior to the challenge

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	sucrose	sucrose
Bifidobacterium lactis Bl-04	Bifidobacterium animalis subsp. lactis Bl-04	2\*109 cfus of probiotic Bifidobacterium lactis Bl-04 (DuPont Nutrition and Health) mixed with 1g of sucrose as a carrier

Primary Outcome Measures

Name	Time	Method
Number of Participants With Rhinovirus-associated Illness Episodes	5 days	Rhinovirus-associated illness episodes: Volunteers who have both a rhinovirus infection and a symptomatic illness will be defined as having a rhinovirus-associated common cold illness.