CompletedNCT02679807MK EPRICUpdated Mar 25, 2020Results posted

Effect of Probiotic on Rhinovirus Induced Colds

An interventional study of Bifidobacterium animalis subsp. lactis Bl-04 and sucrose in Common Cold, sponsored by University of Virginia. Completed. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-25.

Sponsored by University of Virginia · Not applicable, Interventional, and Prevention

Phase: Not applicable
Study type: Interventional
Enrollment: 380
Allocation: Randomized
Ages: 18 Years to 60 Years
Sex: All

Study 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 studied

Common Cold

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Common Cold 180

In context

Common Cold

180 studies on the registry are indexed under Common Cold; 22 are open to participants now.

This study's enrollment of 380 is above the median of 167 across 151 interventional studies indexed under Common Cold.

Browse Common Cold studies →

Lead sponsor

University of Virginia is the lead sponsor of 653 studies on the registry; 134 are open to participants now.

Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

Study design

Phase: Not applicable
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 380 participants (actual)

Study arms

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

Interventions

BiologicalBifidobacterium animalis subsp. lactis Bl-04
Othersucrose

What researchers measure

Primary outcomes

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.
Time frame: 5 days

Results

Posted Mar 17, 2020

Participant flow

Participant flow — Overall Study
Milestone	Bifidobacterium Lactis Bl-04	Placebo
Started	165	169
Completed	143	153
Not completed	22	16

Outcome measures

PrimaryNumber 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.

Time frame:: 5 days
Reported as:: Count of participants · Participants

Number of Participants With Rhinovirus-associated Illness Episodes
Participants	Bifidobacterium Lactis Bl-04	Placebo
Number of Participants With Rhinovirus-associated Illness Episodes	63	60

Adverse events

Collected over Consent/screening through the final study visit on study day 21-28.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Bifidobacterium Lactis Bl-04	0/165 (0%)	1/165 (0.6%)	89/165 (53.9%)
Placebo	0/169 (0%)	0/169 (0%)	84/169 (49.7%)

Most frequent serious events

Most frequent serious events
Event	Bifidobacterium Lactis Bl-04	Placebo
achillles tendon ruptureMusculoskeletal and connective tissue disorders	1/165	0/169

Most frequent other events

Most frequent other events
Event	Bifidobacterium Lactis Bl-04	Placebo
headacheGeneral disorders	39/165	35/169
nasal congestionRespiratory, thoracic and mediastinal disorders	17/165	21/169
oropharyngeal painGastrointestinal disorders	12/165	15/169
coughRespiratory, thoracic and mediastinal disorders	11/165	6/169
dysmenorrheaReproductive system and breast disorders	10/165	7/169

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Bifidobacterium Lactis Bl-04	Placebo	Total
Mean	22.3 ± 6.7	22.2 ± 6.0	22.2 ± 6.4

Sex: Female, Male
Sex: Female, Male(Participants)	Bifidobacterium Lactis Bl-04	Placebo	Total
Female	106	94	200
Male	59	75	134

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Bifidobacterium Lactis Bl-04	Placebo	Total
Hispanic or Latino	6	11	17
Not Hispanic or Latino	132	130	262
Unknown or Not Reported	27	28	55

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Bifidobacterium Lactis Bl-04	Placebo	Total
American Indian or Alaska Native	0	0	0
Asian	16	16	32
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	10	12	22
White	123	120	243
More than one race	1	3	4
Unknown or Not Reported	15	18	33

Study locations

No study locations are listed for this record.

References and documents

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. PubMed 34927036 ↗

Study documents

Study protocol · Oct 13, 2017
Statistical analysis plan · Jul 30, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02679807
Lead sponsor: University of Virginia
Collaborators: Danisco Sweeteners Oy
Responsible party: Ronald Turner, MD (Professor, Department of Pediatrics, University of Virginia) — Principal investigator
First posted: Feb 10, 2016
Start date: Feb 2016
Primary completion: Apr 2018
Completion: Apr 2018
Results posted: Mar 17, 2020
Last update: Mar 25, 2020

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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