Effect of Probiotic on Rhinovirus Induced Colds

NCT ID: NCT02679807

Last Updated: 2020-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 380 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2018-04-30

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.

Conditions

Common Cold

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Bifidobacterium animalis subsp. lactis Bl-04

Intervention Type: BIOLOGICAL

Placebo

sucrose

Group Type: PLACEBO_COMPARATOR

sucrose

Intervention Type: OTHER

Interventions

Bifidobacterium animalis subsp. lactis Bl-04

Intervention Type: BIOLOGICAL

sucrose

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• Female subjects must be using an effective birth control method.

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Danisco Sweeteners Oy

INDUSTRY

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Ronald Turner, MD

Professor, Department of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 34927036 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

18625

Identifier Type: -

Identifier Source: org_study_id