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Completed

NCT Number: NCT02679807

Effect of Probiotic on Rhinovirus Induced Colds

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Bifidobacterium animalis subsp. lactis Bl-04

Biological

Sucrose

Other

Primary outcomes

  1. Number of Participants With Rhinovirus-associated Illness Episodes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • Danisco Sweeteners Oy

Registry information

Acronym: MK EPRIC

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 10, 2016
Registry last updated
Mar 25, 2020

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.

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