Effect of Probiotic on Rhinovirus Induced Colds (MK EPRIC)

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University of Virginia

Status

Completed

Conditions

Common Cold

Treatments

Biological: Bifidobacterium animalis subsp. lactis Bl-04
Other: sucrose

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02679807
18625

Details and patient eligibility

About

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.

Enrollment

380 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

380 participants in 2 patient groups, including a placebo group

Bifidobacterium lactis Bl-04
Active Comparator group
Description:
2*109 cfus of probiotic Bifidobacterium lactis Bl-04 (DuPont Nutrition and Health) mixed with 1g of sucrose as a carrier
Treatment:
Biological: Bifidobacterium animalis subsp. lactis Bl-04
Placebo
Placebo Comparator group
Description:
sucrose
Treatment:
Other: sucrose

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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