Trial Outcomes & Findings for Safety of VSL#3 in Adult Asthmatics (NCT NCT00852124)
NCT ID: NCT00852124
Last Updated: 2023-04-20
Results Overview
Change in FEV in adult asthmatics receiving VSL3# as compared to controls receiving placebo.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
3 participants
Primary outcome timeframe
3 months
Results posted on
2023-04-20
Participant Flow
Participants were recruited between December 2010 and November 2012. Participants were recruited via flyers and newsletters.
Participant milestones
| Measure |
Placebo
Packets similar to VSL#3 taken 2 X daily but not containing active bacteria
VSL#3 or placebo : 1 packet 2 x daily of placebo
|
VSL#3
Packets of VSL#3 (powder containing 8 bacteria believed to be beneficial)taken 2 x daily in food or a cool beverage.
VSL#3 : VSL#3 2 times daily
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
0
|
|
Overall Study
COMPLETED
|
3
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety of VSL#3 in Adult Asthmatics
Baseline characteristics by cohort
| Measure |
Placebo
n=3 Participants
Packets similar to VSL#3 taken 2 X daily but not containing active bacteria
VSL#3 or placebo : 1 packet 2 x daily of placebo
|
VSL#3
Packets of VSL#3 (powder containing 8 bacteria believed to be beneficial)taken 2 x daily in food or a cool beverage.
VSL#3 : VSL#3 2 times daily
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
—
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=39 Participants
|
—
|
3 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
—
|
0 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=39 Participants
|
—
|
2 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=39 Participants
|
—
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
—
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
—
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
—
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
—
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=39 Participants
|
—
|
3 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
—
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
—
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=39 Participants
|
—
|
3 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: 3 people were randomized to placebo arm but no data were analyzed due to early termination of study and small number of patients enrolled.
Change in FEV in adult asthmatics receiving VSL3# as compared to controls receiving placebo.
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
VSL#3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=3 participants at risk
Packets similar to VSL#3 taken 2 X daily but not containing active bacteria
VSL#3 or placebo : 1 packet 2 x daily of placebo
|
VSL#3
Packets of VSL#3 (powder containing 8 bacteria believed to be beneficial)taken 2 x daily in food or a cool beverage.
VSL#3 : VSL#3 2 times daily
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma exacerbation
|
100.0%
3/3 • Number of events 12 • 6 months
No participants received Investigational Product. All thre particpants randomized to placebo arm. Recruitment was ended due to failure to recruit when PI relocated.
|
—
0/0 • 6 months
No participants received Investigational Product. All thre particpants randomized to placebo arm. Recruitment was ended due to failure to recruit when PI relocated.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Number of events 2 • 6 months
No participants received Investigational Product. All thre particpants randomized to placebo arm. Recruitment was ended due to failure to recruit when PI relocated.
|
—
0/0 • 6 months
No participants received Investigational Product. All thre particpants randomized to placebo arm. Recruitment was ended due to failure to recruit when PI relocated.
|
|
Infections and infestations
Fever
|
33.3%
1/3 • Number of events 1 • 6 months
No participants received Investigational Product. All thre particpants randomized to placebo arm. Recruitment was ended due to failure to recruit when PI relocated.
|
—
0/0 • 6 months
No participants received Investigational Product. All thre particpants randomized to placebo arm. Recruitment was ended due to failure to recruit when PI relocated.
|
|
Infections and infestations
Sinus Infection
|
66.7%
2/3 • Number of events 2 • 6 months
No participants received Investigational Product. All thre particpants randomized to placebo arm. Recruitment was ended due to failure to recruit when PI relocated.
|
—
0/0 • 6 months
No participants received Investigational Product. All thre particpants randomized to placebo arm. Recruitment was ended due to failure to recruit when PI relocated.
|
|
Infections and infestations
Viral illness
|
33.3%
1/3 • Number of events 1 • 6 months
No participants received Investigational Product. All thre particpants randomized to placebo arm. Recruitment was ended due to failure to recruit when PI relocated.
|
—
0/0 • 6 months
No participants received Investigational Product. All thre particpants randomized to placebo arm. Recruitment was ended due to failure to recruit when PI relocated.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1 • 6 months
No participants received Investigational Product. All thre particpants randomized to placebo arm. Recruitment was ended due to failure to recruit when PI relocated.
|
—
0/0 • 6 months
No participants received Investigational Product. All thre particpants randomized to placebo arm. Recruitment was ended due to failure to recruit when PI relocated.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place