Effect of Probiotic on Rhinovirus Induced Colds

Common Cold Clinical Trial

— MK EPRIC  

Official title:

Effect of Probiotic on Rhinovirus Induced Colds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02679807
• Other study ID #: 18625
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: April 2018

Study information

• Verified date: March 2020
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

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

Related Conditions & MeSH terms

• Common Cold

Intervention

Biological:
• Bifidobacterium animalis subsp. lactis Bl-04

Other:
• sucrose

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	Danisco Sweeteners Oy

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Rhinovirus-associated Illness Episodes	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.	5 days