Trial Outcomes & Findings for Effects of S. Boulardii and Amoxicillin/Clavulanate on Gut Microbiota (NCT NCT01473368)
NCT ID: NCT01473368
Last Updated: 2017-04-04
Results Overview
Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
53 participants
Primary outcome timeframe
Day 0
Results posted on
2017-04-04
Participant Flow
Participant milestones
| Measure |
Prebiotic (Saccharomyces Boulardii)
Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
|
Antibiotic (Amoxicillin Clavulanate)
Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
|
Combination (Prebiotic and Antibiotic)
Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
|
Control
Control group
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
12
|
15
|
12
|
|
Overall Study
COMPLETED
|
13
|
12
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of S. Boulardii and Amoxicillin/Clavulanate on Gut Microbiota
Baseline characteristics by cohort
| Measure |
Prebiotic (Saccharomyces Boulardii)
n=13 Participants
Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
|
Antibiotic (Amoxicillin Clavulanate)
n=12 Participants
Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
|
Combination (Prebiotic and Antibiotic)
n=12 Participants
Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
|
Control
n=12 Participants
control group
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
49 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Continuous
|
31.6 years
STANDARD_DEVIATION 9.9 • n=99 Participants
|
27.4 years
STANDARD_DEVIATION 6.6 • n=107 Participants
|
34.2 years
STANDARD_DEVIATION 11.4 • n=206 Participants
|
27.2 years
STANDARD_DEVIATION 4.3 • n=7 Participants
|
30.1 years
STANDARD_DEVIATION 8.8 • n=31 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
29 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
20 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=99 Participants
|
12 participants
n=107 Participants
|
12 participants
n=206 Participants
|
12 participants
n=7 Participants
|
49 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Day 0Population: Control participants were not assessed at this time point.
Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms
Outcome measures
| Measure |
Combination (Prebiotic and Antibiotic)
n=12 Participants
Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
|
Control
Control group
|
Prebiotic (Saccharomyces Boulardii)
n=13 Participants
Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
|
Antibiotic (Amoxicillin Clavulanate)
n=12 Participants
Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
|
Core Microbiome
Core Microbiome
|
Prebiotic (Saccharomyces Boulardii) During Treatment
During Treatment
Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
|
Prebiotic (Saccharomyces Boulardii) After Treatment
After Treatment
Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal Symptom Rating Scale
|
17.3 units on a scale
Standard Deviation 2.4
|
—
|
18.7 units on a scale
Standard Deviation 5.4
|
18.7 units on a scale
Standard Deviation 3.8
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms
Outcome measures
| Measure |
Combination (Prebiotic and Antibiotic)
n=12 Participants
Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
|
Control
n=12 Participants
Control group
|
Prebiotic (Saccharomyces Boulardii)
n=13 Participants
Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
|
Antibiotic (Amoxicillin Clavulanate)
n=12 Participants
Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
|
Core Microbiome
Core Microbiome
|
Prebiotic (Saccharomyces Boulardii) During Treatment
During Treatment
Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
|
Prebiotic (Saccharomyces Boulardii) After Treatment
After Treatment
Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal Symptom Rating Scale
|
18.1 Units on a scale
Standard Deviation 3.0
|
19.3 Units on a scale
Standard Deviation 8.1
|
23.2 Units on a scale
Standard Deviation 8.8
|
26.9 Units on a scale
Standard Deviation 14.2
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 14Population: Participants analyzed were those with complete data at Day 14
Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms
Outcome measures
| Measure |
Combination (Prebiotic and Antibiotic)
n=12 Participants
Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
|
Control
n=12 Participants
Control group
|
Prebiotic (Saccharomyces Boulardii)
n=12 Participants
Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
|
Antibiotic (Amoxicillin Clavulanate)
n=11 Participants
Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
|
Core Microbiome
Core Microbiome
|
Prebiotic (Saccharomyces Boulardii) During Treatment
During Treatment
Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
|
Prebiotic (Saccharomyces Boulardii) After Treatment
After Treatment
Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal Symptoms Response Score
|
16.8 units on a scale
Standard Deviation 1.6
|
18.1 units on a scale
Standard Deviation 4.3
|
19.3 units on a scale
Standard Deviation 5.1
|
20.3 units on a scale
Standard Deviation 5.9
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 21Population: Participants analyzed were those with complete data at Day 14
Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms
Outcome measures
| Measure |
Combination (Prebiotic and Antibiotic)
n=12 Participants
Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
|
Control
n=12 Participants
Control group
|
Prebiotic (Saccharomyces Boulardii)
n=12 Participants
Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
|
Antibiotic (Amoxicillin Clavulanate)
n=11 Participants
Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
|
Core Microbiome
Core Microbiome
|
Prebiotic (Saccharomyces Boulardii) During Treatment
During Treatment
Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
|
Prebiotic (Saccharomyces Boulardii) After Treatment
After Treatment
Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal Symptoms Response Scale
|
16.5 units on a scale
Standard Deviation 2.9
|
15.8 units on a scale
Standard Deviation 2.3
|
19.3 units on a scale
Standard Deviation 5.7
|
18.4 units on a scale
Standard Deviation 5.8
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day -7 to Day 21Control arm was not assessed as there was no intervention for this group. Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Day 3, Day 7, Day 10, Day 13 After Treatment: Average of Day 21
Outcome measures
| Measure |
Combination (Prebiotic and Antibiotic)
n=12 Participants
Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
|
Control
Control group
|
Prebiotic (Saccharomyces Boulardii)
n=13 Participants
Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
|
Antibiotic (Amoxicillin Clavulanate)
n=13 Participants
Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
|
Core Microbiome
Core Microbiome
|
Prebiotic (Saccharomyces Boulardii) During Treatment
During Treatment
Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
|
Prebiotic (Saccharomyces Boulardii) After Treatment
After Treatment
Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
|
|---|---|---|---|---|---|---|---|
|
Prevalence of Escherichia in Stool
|
0.1 percentage of total bacteria
Standard Deviation 0
|
—
|
0.0 percentage of total bacteria
Standard Deviation 0
|
0.0 percentage of total bacteria
Standard Deviation 0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day -7 to Day 21Control arm was not assessed as there was no intervention for this group. Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Day 3, Day 7, Day 10, Day 13 After Treatment: Average of Day 21
Outcome measures
| Measure |
Combination (Prebiotic and Antibiotic)
n=11 Participants
Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
|
Control
Control group
|
Prebiotic (Saccharomyces Boulardii)
n=12 Participants
Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
|
Antibiotic (Amoxicillin Clavulanate)
n=12 Participants
Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
|
Core Microbiome
Core Microbiome
|
Prebiotic (Saccharomyces Boulardii) During Treatment
During Treatment
Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
|
Prebiotic (Saccharomyces Boulardii) After Treatment
After Treatment
Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
|
|---|---|---|---|---|---|---|---|
|
Prevalence of Escherichia in Stool
|
0.2 percentage of total bacteria
Standard Deviation 0
|
—
|
0.1 percentage of total bacteria
Standard Deviation 0
|
4.5 percentage of total bacteria
Standard Deviation 0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day -7 to Day 21Control arm was not assessed as there was no intervention for this group. Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Day 3, Day 7, Day 10, Day 13 After Treatment: Average of Day 21
Outcome measures
| Measure |
Combination (Prebiotic and Antibiotic)
n=12 Participants
Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
|
Control
Control group
|
Prebiotic (Saccharomyces Boulardii)
n=12 Participants
Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
|
Antibiotic (Amoxicillin Clavulanate)
n=12 Participants
Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
|
Core Microbiome
Core Microbiome
|
Prebiotic (Saccharomyces Boulardii) During Treatment
During Treatment
Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
|
Prebiotic (Saccharomyces Boulardii) After Treatment
After Treatment
Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
|
|---|---|---|---|---|---|---|---|
|
Prevalence of Escherichia in Stool
|
0.2 percentage of total bacteria
Standard Deviation 0
|
—
|
0.0 percentage of total bacteria
Standard Deviation 0
|
2.9 percentage of total bacteria
Standard Deviation 0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 0 to Day 21Core Microbiome includes control samples and baseline samples (Day -7 and Day 0) for antibiotic, probiotic, and combination groups. Data for Core microbiome for individual arms are not available. Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Day 3, Day 7, Day 10, Day 13 After Treatment: Average of Day 21
Outcome measures
| Measure |
Combination (Prebiotic and Antibiotic)
n=12 Participants
Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
|
Control
n=11 Participants
Control group
|
Prebiotic (Saccharomyces Boulardii)
n=13 Participants
Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
|
Antibiotic (Amoxicillin Clavulanate)
n=12 Participants
Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
|
Core Microbiome
n=49 Participants
Core Microbiome
|
Prebiotic (Saccharomyces Boulardii) During Treatment
n=12 Participants
During Treatment
Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
|
Prebiotic (Saccharomyces Boulardii) After Treatment
n=12 Participants
After Treatment
Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
|
|---|---|---|---|---|---|---|---|
|
Operational Taxonomic Units
|
461.1 units
Standard Deviation 228.2
|
668.8 units
Standard Deviation 188.4
|
449.8 units
Standard Deviation 210.1
|
509.9 units
Standard Deviation 251.9
|
730.9 units
Standard Deviation 240.4
|
776.7 units
Standard Deviation 167.6
|
776.7 units
Standard Deviation 749.1
|
Adverse Events
Prebiotic (Saccharomyces Boulardii)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Antibiotic (Amoxicillin Clavulanate)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Combination (Prebiotic and Antibiotic)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Control
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 |
Prebiotic (Saccharomyces Boulardii)
n=13 participants at risk
Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
|
Antibiotic (Amoxicillin Clavulanate)
n=12 participants at risk
Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
|
Combination (Prebiotic and Antibiotic)
n=12 participants at risk
Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
|
Control
n=12 participants at risk
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
30.8%
4/13
|
8.3%
1/12
|
0.00%
0/12
|
8.3%
1/12
|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
1/13
|
8.3%
1/12
|
0.00%
0/12
|
0.00%
0/12
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/13
|
8.3%
1/12
|
0.00%
0/12
|
0.00%
0/12
|
|
Gastrointestinal disorders
Constipation
|
15.4%
2/13
|
0.00%
0/12
|
0.00%
0/12
|
8.3%
1/12
|
|
Gastrointestinal disorders
diarrhea
|
7.7%
1/13
|
25.0%
3/12
|
8.3%
1/12
|
0.00%
0/12
|
|
Gastrointestinal disorders
dyspepsia
|
0.00%
0/13
|
8.3%
1/12
|
0.00%
0/12
|
0.00%
0/12
|
|
Gastrointestinal disorders
eructation
|
7.7%
1/13
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
|
Gastrointestinal disorders
flatulence
|
15.4%
2/13
|
0.00%
0/12
|
0.00%
0/12
|
8.3%
1/12
|
|
Gastrointestinal disorders
gastrointestinal motility disorder
|
0.00%
0/13
|
8.3%
1/12
|
0.00%
0/12
|
0.00%
0/12
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
7.7%
1/13
|
16.7%
2/12
|
0.00%
0/12
|
0.00%
0/12
|
|
Gastrointestinal disorders
infrequent bowel movements
|
0.00%
0/13
|
0.00%
0/12
|
8.3%
1/12
|
0.00%
0/12
|
|
Gastrointestinal disorders
regurgitation
|
7.7%
1/13
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
decreased appetite
|
7.7%
1/13
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
|
Reproductive system and breast disorders
vulvovaginal rash
|
0.00%
0/13
|
16.7%
2/12
|
0.00%
0/12
|
0.00%
0/12
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place