Clinical trial NCT02679807: Effect of Probiotic on Rhinovirus Induced Colds
Official title: Effect of Probiotic on Rhinovirus Induced Colds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Common Cold
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Danisco Sweeteners Oy
First posted: 2016-02-10
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Rhinovirus-associated Illness Episodes
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Turner RB, Lehtoranta L, Hibberd A, Mannikko S, Zabel B, Yeung N, Huttunen T, Burns FR, Lehtinen MJ. Effect of Bifidobacterium animalis spp. lactis Bl-04 on Rhinovirus-Induced Colds: A Randomized, Placebo-Controlled, Single-Center, Phase II Trial in Healthy Volunteers. EClinicalMedicine. 2021 Dec 3;43:101224. doi: 10.1016/j.eclinm.2021.101224. eCollection 2022 Jan.