Trial Outcomes & Findings for Use of Probiotics as Adjunctive Treatment for Chronic Rhinosinusitis (NCT NCT00396162)
NCT ID: NCT00396162
Last Updated: 2016-09-20
Results Overview
Mean reduction (and Standard deviation) in SNOT-20 scores, from baseline to 8 week measurements. SinoNasal Outcome Test measures symptom severity. It is a summary score, ranging from 0 to 100 with 100 indicating worse symptoms. Since 100 represents more severe symptoms, the changes represented here are reductions in SNOT-scores, even though they are not expressed as negative numbers.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
77 participants
Primary outcome timeframe
8 weeks
Results posted on
2016-09-20
Participant Flow
82 participants were screened . 77 enrolled.
Participant milestones
| Measure |
Probiotic
The study protocol scheduled daily oral supplementation of either the probiotic or the placebo twice daily for four weeks. The probiotic product was a chewable tablet containing 500 million active cells of L rhamnosus R0011 strain per tablet. Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
|
Placebo
Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
38
|
|
Overall Study
COMPLETED
|
37
|
35
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Probiotic
The study protocol scheduled daily oral supplementation of either the probiotic or the placebo twice daily for four weeks. The probiotic product was a chewable tablet containing 500 million active cells of L rhamnosus R0011 strain per tablet. Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
|
Placebo
Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
Baseline Characteristics
Use of Probiotics as Adjunctive Treatment for Chronic Rhinosinusitis
Baseline characteristics by cohort
| Measure |
Probiotic
n=39 Participants
drug
probiotic containing L.rhamnosus R0011 strain: 500 million active cells of L rhamnosus R0011 strain per tablet bid for 4 weeks
|
Placebo Pill
n=38 Participants
Placebo pills on same schedule as active intervention.
probiotic containing L.rhamnosus R0011 strain: 500 million active cells of L rhamnosus R0011 strain per tablet bid for 4 weeks
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.4 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
49.6 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
49.5 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
asthma
No asthma
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
asthma
intermittent and mild asthma
|
13 participants
n=5 Participants
|
10 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
asthma
moderate-severe asthma
|
12 participants
n=5 Participants
|
14 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
aspirin sensitivity
Aspirin Sensitivity
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
aspirin sensitivity
No aspirin sensitivity
|
27 participants
n=5 Participants
|
26 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
SinoNasal Outcome Test Score (SNOT-20)
|
36.4 units on a scale
STANDARD_DEVIATION 16.2 • n=5 Participants
|
39.5 units on a scale
STANDARD_DEVIATION 19.8 • n=7 Participants
|
37.9 units on a scale
STANDARD_DEVIATION 17.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksMean reduction (and Standard deviation) in SNOT-20 scores, from baseline to 8 week measurements. SinoNasal Outcome Test measures symptom severity. It is a summary score, ranging from 0 to 100 with 100 indicating worse symptoms. Since 100 represents more severe symptoms, the changes represented here are reductions in SNOT-scores, even though they are not expressed as negative numbers.
Outcome measures
| Measure |
Probiotic
n=37 Participants
The study protocol scheduled daily oral supplementation of either the probiotic or the placebo twice daily for four weeks. The probiotic product was a chewable tablet containing 500 million active cells of L rhamnosus R0011 strain per tablet. Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
|
Placebo
n=35 Participants
Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
|
|---|---|---|
|
Mean Reduction in SNOT-20 Scores
|
1.8 units on a scale
Standard Deviation 12
|
5.5 units on a scale
Standard Deviation 14
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The sample size on the placebo side is reduced due to some study participants not reporting their 8 week survey
Totals of all side effects for placebo group and treatment group over the course of the eight week trial (including patients who dropped from the study after baseline measurement). Individual categories of side-effects are listed in Adverse events section.
Outcome measures
| Measure |
Probiotic
n=35 Participants
The study protocol scheduled daily oral supplementation of either the probiotic or the placebo twice daily for four weeks. The probiotic product was a chewable tablet containing 500 million active cells of L rhamnosus R0011 strain per tablet. Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
|
Placebo
n=37 Participants
Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
|
|---|---|---|
|
Side Effect Summary
|
17 participants
|
14 participants
|
SECONDARY outcome
Timeframe: At 8 weeks after baseline measuresMean number of days that antibiotics were used in the subgroup (placebo vs Probiotic arm)
Outcome measures
| Measure |
Probiotic
n=35 Participants
The study protocol scheduled daily oral supplementation of either the probiotic or the placebo twice daily for four weeks. The probiotic product was a chewable tablet containing 500 million active cells of L rhamnosus R0011 strain per tablet. Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
|
Placebo
n=37 Participants
Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
|
|---|---|---|
|
Mean Number of Days of Antibiotic Use During the Study Period (0-8 Weeks)
|
1.9 days
Standard Deviation 5.5
|
0.8 days
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: 8 weeksOutcome measures
| Measure |
Probiotic
n=37 Participants
The study protocol scheduled daily oral supplementation of either the probiotic or the placebo twice daily for four weeks. The probiotic product was a chewable tablet containing 500 million active cells of L rhamnosus R0011 strain per tablet. Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
|
Placebo
n=35 Participants
Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
|
|---|---|---|
|
Mean Number of Days of Steroid Spray Use for Each Group
|
2.8 days
Standard Deviation 7.4
|
0.4 days
Standard Deviation 2.2
|
Adverse Events
Active Intervention
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active Intervention
n=39 participants at risk
The study protocol scheduled daily oral supplementation of either the probiotic or the placebo twice daily for four weeks. The probiotic product was a chewable tablet containing 500 million active cells of L rhamnosus R0011 strain per tablet. Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
|
Placebo
n=38 participants at risk
Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
|
|---|---|---|
|
Gastrointestinal disorders
bloating
|
17.9%
7/39
|
23.7%
9/38
|
|
Gastrointestinal disorders
diarrhea
|
20.5%
8/39
|
26.3%
10/38
|
|
Gastrointestinal disorders
abdominal pain
|
17.9%
7/39
|
18.4%
7/38
|
|
Gastrointestinal disorders
loose stools
|
23.1%
9/39
|
21.1%
8/38
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place