Trial Outcomes & Findings for Effect of Probiotic on the Innate and Adaptive Host Response to Rhinovirus (EPIARR) (NCT NCT01669603)

NCT ID: NCT01669603

Last Updated: 2017-04-25

Results Overview

Nasal lavage will be performed to collect and measure IL-8.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 789 participants
• Primary outcome timeframe: 72 hours
• Results posted on: 2017-04-25

Participant Flow

789 subjects were screened for participation. 190 subjects met all study criteria for randomization to study intervention.

Participant milestones

Measure	Bifidobacterium Animalis Lactis Bl-04 Bifidobacterium animalis subspecies lactis Bl-04 as powder mixed into drink. Bifidobacterium lactis Bl-04: The study product will be a 2\*109 cfus of probiotic Bifidobacterium lactis Bl-04 mixed with 1g of sucrose as a carrier.	Placebo Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product. Placebo: Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.
Overall Study STARTED	95	95
Overall Study COMPLETED	58	57
Overall Study NOT COMPLETED	37	38

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Analysis limited to participants who were susceptible to RV39, had no virus detected in nasal lavage on Day 0, were infected and completed the study.

Baseline characteristics by cohort

Measure	Bifidobacterium Animalis Lactis Bl-04 n=95 Participants Bifidobacterium animalis subspecies lactis Bl-04 as powder mixed into drink. Bifidobacterium lactis Bl-04: The study product will be a 2\*109 cfus of probiotic Bifidobacterium lactis Bl-04 mixed with 1g of sucrose as a carrier.	Placebo n=95 Participants Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product. Placebo: Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.	Total n=190 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=58 Participants • Analysis limited to participants who were susceptible to RV39, had no virus detected in nasal lavage on Day 0, were infected and completed the study.	0 Participants n=57 Participants • Analysis limited to participants who were susceptible to RV39, had no virus detected in nasal lavage on Day 0, were infected and completed the study.	0 Participants n=115 Participants • Analysis limited to participants who were susceptible to RV39, had no virus detected in nasal lavage on Day 0, were infected and completed the study.
Age, Categorical Between 18 and 65 years	58 Participants n=58 Participants • Analysis limited to participants who were susceptible to RV39, had no virus detected in nasal lavage on Day 0, were infected and completed the study.	57 Participants n=57 Participants • Analysis limited to participants who were susceptible to RV39, had no virus detected in nasal lavage on Day 0, were infected and completed the study.	115 Participants n=115 Participants • Analysis limited to participants who were susceptible to RV39, had no virus detected in nasal lavage on Day 0, were infected and completed the study.
Age, Categorical >=65 years	0 Participants n=58 Participants • Analysis limited to participants who were susceptible to RV39, had no virus detected in nasal lavage on Day 0, were infected and completed the study.	0 Participants n=57 Participants • Analysis limited to participants who were susceptible to RV39, had no virus detected in nasal lavage on Day 0, were infected and completed the study.	0 Participants n=115 Participants • Analysis limited to participants who were susceptible to RV39, had no virus detected in nasal lavage on Day 0, were infected and completed the study.
Age, Continuous	22 years STANDARD_DEVIATION 6 • n=58 Participants • analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study	23 years STANDARD_DEVIATION 7 • n=57 Participants • analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study	23 years STANDARD_DEVIATION 7 • n=115 Participants • analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study
Sex: Female, Male Female	39 Participants n=58 Participants • analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study	33 Participants n=57 Participants • analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study	72 Participants n=115 Participants • analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study
Sex: Female, Male Male	19 Participants n=58 Participants • analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study	24 Participants n=57 Participants • analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study	43 Participants n=115 Participants • analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=58 Participants • analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study	4 Participants n=57 Participants • analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study	7 Participants n=115 Participants • analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study
Ethnicity (NIH/OMB) Not Hispanic or Latino	54 Participants n=58 Participants • analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study	52 Participants n=57 Participants • analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study	106 Participants n=115 Participants • analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=58 Participants • analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study	1 Participants n=57 Participants • analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study	2 Participants n=115 Participants • analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=58 Participants • analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study	0 Participants n=57 Participants • analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study	0 Participants n=115 Participants • analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study
Race (NIH/OMB) Asian	2 Participants n=58 Participants • analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study	8 Participants n=57 Participants • analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study	10 Participants n=115 Participants • analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=58 Participants • analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study	0 Participants n=57 Participants • analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study	0 Participants n=115 Participants • analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study
Race (NIH/OMB) Black or African American	3 Participants n=58 Participants • analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study	2 Participants n=57 Participants • analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study	5 Participants n=115 Participants • analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study
Race (NIH/OMB) White	52 Participants n=58 Participants • analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study	46 Participants n=57 Participants • analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study	98 Participants n=115 Participants • analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study
Race (NIH/OMB) More than one race	0 Participants n=58 Participants • analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study	0 Participants n=57 Participants • analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study	0 Participants n=115 Participants • analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=58 Participants • analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study	1 Participants n=57 Participants • analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study	2 Participants n=115 Participants • analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study
Region of Enrollment United States	95 participants n=95 Participants	95 participants n=95 Participants	190 participants n=190 Participants

PRIMARY outcome

Timeframe: 72 hours

Population: analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study

Nasal lavage will be performed to collect and measure IL-8.

Outcome measures

Measure	Bifidobacterium Animalis Lactis Bl-04 n=58 Participants Bifidobacterium animalis subspecies lactis Bl-04 as powder mixed into drink. Bifidobacterium lactis Bl-04: The study product will be a 2\*109 cfus of probiotic Bifidobacterium lactis Bl-04 mixed with 1g of sucrose as a carrier.	Placebo n=57 Participants Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product. Placebo: Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.
Interleukin-8 (IL-8)	133 pg/ml Standard Deviation 2.5	122 pg/ml Standard Deviation 2.9

Adverse Events

Bifidobacterium Animalis Lactis Bl-04

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Bifidobacterium Animalis Lactis Bl-04 n=95 participants at risk Bifidobacterium animalis subspecies lactis Bl-04 as powder mixed into drink. Bifidobacterium lactis Bl-04: The study product will be a 2\*109 cfus of probiotic Bifidobacterium lactis Bl-04 mixed with 1g of sucrose as a carrier.	Placebo n=95 participants at risk Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product. Placebo: Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.
Gastrointestinal disorders gastrointestinal	4.2% 4/95 • Number of events 4 • 7 weeks	0.00% 0/95 • 7 weeks
Respiratory, thoracic and mediastinal disorders respiratory	0.00% 0/95 • 7 weeks	1.1% 1/95 • Number of events 1 • 7 weeks

Additional Information

Ronald Turner

University of Virginia

Email: rbt2n@virginia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place