Effect of Probiotic on Rhinovirus Induced Colds (MK EPRIC)

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.

Study Overview

• Status: Completed
• Conditions: Common Cold
• Intervention / Treatment: Biological: Bifidobacterium animalis subsp. lactis Bl-04; Other: sucrose

• Study Type: Interventional
• Enrollment (Actual): 380
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Rhinovirus-associated Illness Episodes	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.	5 days

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: Danisco Sweeteners Oy

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: February 8, 2016
• First Submitted That Met QC Criteria: February 8, 2016
• First Posted (Estimate): February 10, 2016

Study Record Updates

• Last Update Posted (Actual): March 25, 2020
• Last Update Submitted That Met QC Criteria: March 16, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Picornaviridae Infections; Common Cold
• Other Study ID Numbers: 18625

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No