Effect of Probiotic on Rhinovirus Induced Colds (MK EPRIC)

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

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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