Effect of Probiotic on Rhinovirus Induced Colds

NCT02679807 | Completed Results

• 1 other identifier: 18625
• Study Type: interventional
• Target: 380
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Bifidobacterium lactis Bl-04

ACTIVE COMPARATOR

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

PLACEBO COMPARATOR

sucrose

Other: sucrose

Interventions

Bifidobacterium animalis subsp. lactis Bl-04 BIOLOGICAL

Bifidobacterium lactis Bl-04

sucrose OTHER

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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
• Use of any anti-inflammatory (steroids or NSAIDs) or cough/cold or allergy preparation in the two weeks prior to the challenge

Sponsors & Collaborators

• University of Virginia: lead
• Danisco Sweeteners Oy: collaborator

Related Publications (1)

• 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.

  PMID: 34927036 DERIVED

MeSH Terms

Conditions

Common Cold

Interventions

Sucrose

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Results Point of Contact

• Title: Ronald Turner
• Organization: University of Virginia

rbt2n@virginia.edu

434-981-9141

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Pediatrics

Study Record Dates

• First Submitted: February 8, 2016
• First Posted: February 10, 2016
• Study Start: February 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: March 25, 2020
• Results First Posted: March 17, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share