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Effect of Probiotic on Rhinovirus Induced Colds

NCT02679807 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 380

Last updated 2020-03-25

Study results available
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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.

Conditions

  • Common Cold

Interventions

BIOLOGICAL

Bifidobacterium animalis subsp. lactis Bl-04

OTHER

sucrose

Sponsors & Collaborators

  • Danisco Sweeteners Oy

    collaborator INDUSTRY

  • University of Virginia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2018-04-30
Completion
2018-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02679807 on ClinicalTrials.gov