Trial Outcomes & Findings for Effect of Probiotic on Rhinovirus Induced Colds (NCT NCT02679807)

NCT ID: NCT02679807

Last Updated: 2020-03-25

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 380 participants
• Primary outcome timeframe: 5 days
• Results posted on: 2020-03-25

Participant Flow

All volunteers who signed consent were considered enrolled in the study per UVA IRB policy. 334 of these 380 volunteers were randomized to treatment after pre-treatment screening was complete.

Participant milestones

Measure	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 Bifidobacterium animalis subsp. lactis Bl-04	Placebo sucrose sucrose
Overall Study STARTED	165	169
Overall Study COMPLETED	143	153
Overall Study NOT COMPLETED	22	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Probiotic on Rhinovirus Induced Colds

Baseline characteristics by cohort

Measure	Bifidobacterium Lactis Bl-04 n=165 Participants 2\*109 cfus of probiotic Bifidobacterium lactis Bl-04 (DuPont Nutrition and Health) mixed with 1g of sucrose as a carrier Bifidobacterium animalis subsp. lactis Bl-04	Placebo n=169 Participants sucrose sucrose	Total n=334 Participants Total of all reporting groups
Age, Continuous	22.3 years STANDARD_DEVIATION 6.7 • n=5 Participants	22.2 years STANDARD_DEVIATION 6.0 • n=7 Participants	22.2 years STANDARD_DEVIATION 6.4 • n=5 Participants
Sex: Female, Male Female	106 Participants n=5 Participants	94 Participants n=7 Participants	200 Participants n=5 Participants
Sex: Female, Male Male	59 Participants n=5 Participants	75 Participants n=7 Participants	134 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	11 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	132 Participants n=5 Participants	130 Participants n=7 Participants	262 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	27 Participants n=5 Participants	28 Participants n=7 Participants	55 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) White	123 Participants n=5 Participants	120 Participants n=7 Participants	243 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	15 Participants n=5 Participants	18 Participants n=7 Participants	33 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 days

Population: Volunteers who were challenged with rhinovirus, completed the study period and did not have any evidence by PCR or serology of a viral infection with a virus other than the challenge virus

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.

Outcome measures

Measure	Bifidobacterium Lactis Bl-04 n=112 Participants 2\*109 cfus of probiotic Bifidobacterium lactis Bl-04 (DuPont Nutrition and Health) mixed with 1g of sucrose as a carrier Bifidobacterium animalis subsp. lactis Bl-04	Placebo n=120 Participants sucrose sucrose
Number of Participants With Rhinovirus-associated Illness Episodes	63 Participants	60 Participants

Adverse Events

Bifidobacterium Lactis Bl-04

Serious events: 1 serious events

Other events: 89 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 84 other events

Deaths: 0 deaths

Serious adverse events

Measure	Bifidobacterium Lactis Bl-04 n=165 participants at risk 2\*109 cfus of probiotic Bifidobacterium lactis Bl-04 (DuPont Nutrition and Health) mixed with 1g of sucrose as a carrier Bifidobacterium animalis subsp. lactis Bl-04	Placebo n=169 participants at risk sucrose sucrose
Musculoskeletal and connective tissue disorders achillles tendon rupture	0.61% 1/165 • Number of events 1 • Consent/screening through the final study visit on study day 21-28. For the purposes of this study using experimental rhinovirus infection, physical signs and symptoms that are expected to be associated with the common cold should not be reported as adverse events. The following physical signs and symptoms are expected to be associated with the common cold: nasal obstruction (nasal stuffiness), coryza (runny nose), sore throat, cough, sneezing, myalgia, headache, feverishness, chills, loss of appetite and malaise.	0.00% 0/169 • Consent/screening through the final study visit on study day 21-28. For the purposes of this study using experimental rhinovirus infection, physical signs and symptoms that are expected to be associated with the common cold should not be reported as adverse events. The following physical signs and symptoms are expected to be associated with the common cold: nasal obstruction (nasal stuffiness), coryza (runny nose), sore throat, cough, sneezing, myalgia, headache, feverishness, chills, loss of appetite and malaise.

Other adverse events

Measure	Bifidobacterium Lactis Bl-04 n=165 participants at risk 2\*109 cfus of probiotic Bifidobacterium lactis Bl-04 (DuPont Nutrition and Health) mixed with 1g of sucrose as a carrier Bifidobacterium animalis subsp. lactis Bl-04	Placebo n=169 participants at risk sucrose sucrose
General disorders headache	23.6% 39/165 • Number of events 51 • Consent/screening through the final study visit on study day 21-28. For the purposes of this study using experimental rhinovirus infection, physical signs and symptoms that are expected to be associated with the common cold should not be reported as adverse events. The following physical signs and symptoms are expected to be associated with the common cold: nasal obstruction (nasal stuffiness), coryza (runny nose), sore throat, cough, sneezing, myalgia, headache, feverishness, chills, loss of appetite and malaise.	20.7% 35/169 • Number of events 38 • Consent/screening through the final study visit on study day 21-28. For the purposes of this study using experimental rhinovirus infection, physical signs and symptoms that are expected to be associated with the common cold should not be reported as adverse events. The following physical signs and symptoms are expected to be associated with the common cold: nasal obstruction (nasal stuffiness), coryza (runny nose), sore throat, cough, sneezing, myalgia, headache, feverishness, chills, loss of appetite and malaise.
Respiratory, thoracic and mediastinal disorders nasal congestion	10.3% 17/165 • Number of events 17 • Consent/screening through the final study visit on study day 21-28. For the purposes of this study using experimental rhinovirus infection, physical signs and symptoms that are expected to be associated with the common cold should not be reported as adverse events. The following physical signs and symptoms are expected to be associated with the common cold: nasal obstruction (nasal stuffiness), coryza (runny nose), sore throat, cough, sneezing, myalgia, headache, feverishness, chills, loss of appetite and malaise.	12.4% 21/169 • Number of events 21 • Consent/screening through the final study visit on study day 21-28. For the purposes of this study using experimental rhinovirus infection, physical signs and symptoms that are expected to be associated with the common cold should not be reported as adverse events. The following physical signs and symptoms are expected to be associated with the common cold: nasal obstruction (nasal stuffiness), coryza (runny nose), sore throat, cough, sneezing, myalgia, headache, feverishness, chills, loss of appetite and malaise.
Gastrointestinal disorders oropharyngeal pain	7.3% 12/165 • Number of events 15 • Consent/screening through the final study visit on study day 21-28. For the purposes of this study using experimental rhinovirus infection, physical signs and symptoms that are expected to be associated with the common cold should not be reported as adverse events. The following physical signs and symptoms are expected to be associated with the common cold: nasal obstruction (nasal stuffiness), coryza (runny nose), sore throat, cough, sneezing, myalgia, headache, feverishness, chills, loss of appetite and malaise.	8.9% 15/169 • Number of events 15 • Consent/screening through the final study visit on study day 21-28. For the purposes of this study using experimental rhinovirus infection, physical signs and symptoms that are expected to be associated with the common cold should not be reported as adverse events. The following physical signs and symptoms are expected to be associated with the common cold: nasal obstruction (nasal stuffiness), coryza (runny nose), sore throat, cough, sneezing, myalgia, headache, feverishness, chills, loss of appetite and malaise.
Respiratory, thoracic and mediastinal disorders cough	6.7% 11/165 • Number of events 11 • Consent/screening through the final study visit on study day 21-28. For the purposes of this study using experimental rhinovirus infection, physical signs and symptoms that are expected to be associated with the common cold should not be reported as adverse events. The following physical signs and symptoms are expected to be associated with the common cold: nasal obstruction (nasal stuffiness), coryza (runny nose), sore throat, cough, sneezing, myalgia, headache, feverishness, chills, loss of appetite and malaise.	3.6% 6/169 • Number of events 6 • Consent/screening through the final study visit on study day 21-28. For the purposes of this study using experimental rhinovirus infection, physical signs and symptoms that are expected to be associated with the common cold should not be reported as adverse events. The following physical signs and symptoms are expected to be associated with the common cold: nasal obstruction (nasal stuffiness), coryza (runny nose), sore throat, cough, sneezing, myalgia, headache, feverishness, chills, loss of appetite and malaise.
Reproductive system and breast disorders dysmenorrhea	6.1% 10/165 • Number of events 13 • Consent/screening through the final study visit on study day 21-28. For the purposes of this study using experimental rhinovirus infection, physical signs and symptoms that are expected to be associated with the common cold should not be reported as adverse events. The following physical signs and symptoms are expected to be associated with the common cold: nasal obstruction (nasal stuffiness), coryza (runny nose), sore throat, cough, sneezing, myalgia, headache, feverishness, chills, loss of appetite and malaise.	4.1% 7/169 • Number of events 9 • Consent/screening through the final study visit on study day 21-28. For the purposes of this study using experimental rhinovirus infection, physical signs and symptoms that are expected to be associated with the common cold should not be reported as adverse events. The following physical signs and symptoms are expected to be associated with the common cold: nasal obstruction (nasal stuffiness), coryza (runny nose), sore throat, cough, sneezing, myalgia, headache, feverishness, chills, loss of appetite and malaise.

Additional Information

Ronald Turner

University of Virginia

Phone: 434-981-9141

Email: rbt2n@virginia.edu

Results disclosure agreements

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