Trial Outcomes & Findings for Mechanisms of Preventing Antibiotic-Associated Diarrhea and the Role for Probiotics (NCT NCT03755765)
NCT ID: NCT03755765
Last Updated: 2023-02-17
Results Overview
Level of fecal short-chain fatty acid acetate (SCFA) after administration of amoxicillin clavulanate
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
66 participants
Primary outcome timeframe
day 0 (post run-in), 7, 14, 21, 30
Results posted on
2023-02-17
Participant Flow
Participant milestones
| Measure |
Control
Yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12) and Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet: Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
Control: Yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12)
|
BB-12
Bifidobacterium animalis subsp. lactis BB-12 (BB-12)-supplemented yogurt and Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet: Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
BB-12: Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt
|
Not Randomized
Withdrawals prior to randomization
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
42
|
4
|
|
Overall Study
COMPLETED
|
18
|
38
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
4
|
Reasons for withdrawal
| Measure |
Control
Yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12) and Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet: Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
Control: Yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12)
|
BB-12
Bifidobacterium animalis subsp. lactis BB-12 (BB-12)-supplemented yogurt and Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet: Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
BB-12: Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt
|
Not Randomized
Withdrawals prior to randomization
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
4
|
Baseline Characteristics
Mechanisms of Preventing Antibiotic-Associated Diarrhea and the Role for Probiotics
Baseline characteristics by cohort
| Measure |
Control
n=20 Participants
Yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12) and Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet: Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
Control: Yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12)
|
BB-12
n=42 Participants
Bifidobacterium animalis subsp. lactis BB-12 (BB-12)-supplemented yogurt and Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet: Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
BB-12: Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt
|
Not Randomized
n=4 Participants
Withdrawals prior to randomization
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
29.4 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
29.6 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
31.8 years
STANDARD_DEVIATION 21.6 • n=5 Participants
|
29.7 years
STANDARD_DEVIATION 10.6 • n=4 Participants
|
|
Sex/Gender, Customized
Female
|
11 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Male
|
9 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Not reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Health insurance status
Yes
|
20 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Health insurance status
No
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Household smoking
No
|
18 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Household smoking
Yes
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Marital status
Married
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Marital status
Living with a partner
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Marital status
Single
|
14 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Marital status
Separated
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Marital status
Divorced
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Marital status
Widowed
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Annual gross total income
Less than $15,000
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Annual gross total income
$15,000-$29,999
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Annual gross total income
$30,000-$49,999
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Annual gross total income
$50,000-$74,999
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Annual gross total income
$75,000-$99,999
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Annual gross total income
$100,000-$150,999
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Annual gross total income
$150,000-$200,000
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Annual gross total income
More than $200,000
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Annual gross total income
Prefer not to answer
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Annual gross total income
Unknown/Not Reported
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: day 0 (post run-in), 7, 14, 21, 30Population: Number of samples received
Level of fecal short-chain fatty acid acetate (SCFA) after administration of amoxicillin clavulanate
Outcome measures
| Measure |
Control
n=12 Participants
Yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12) and Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet: Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
Control: Yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12)
|
BB-12
n=29 Participants
Bifidobacterium animalis subsp. lactis BB-12 (BB-12)-supplemented yogurt and Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet: Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
BB-12: Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt
|
|---|---|---|
|
Level of Fecal Short-chain Fatty Acid (SCFA) Acetate
Day 0
|
53.1 micromolar (μM)
Standard Deviation 18.0
|
45.2 micromolar (μM)
Standard Deviation 20.3
|
|
Level of Fecal Short-chain Fatty Acid (SCFA) Acetate
Day 7
|
42.3 micromolar (μM)
Standard Deviation 17.5
|
38.1 micromolar (μM)
Standard Deviation 17.6
|
|
Level of Fecal Short-chain Fatty Acid (SCFA) Acetate
Day 14
|
36.8 micromolar (μM)
Standard Deviation 11.1
|
40.8 micromolar (μM)
Standard Deviation 16.1
|
|
Level of Fecal Short-chain Fatty Acid (SCFA) Acetate
Day 21
|
43.8 micromolar (μM)
Standard Deviation 17.6
|
50.5 micromolar (μM)
Standard Deviation 20.9
|
|
Level of Fecal Short-chain Fatty Acid (SCFA) Acetate
Day 30
|
39.8 micromolar (μM)
Standard Deviation 14.3
|
44.5 micromolar (μM)
Standard Deviation 14.1
|
SECONDARY outcome
Timeframe: day 0 (post run-in), 7, 14, 21, 30Population: Number of samples received
Level of fecal short-chain fatty acid propionate after administration of amoxicillin clavulanate
Outcome measures
| Measure |
Control
n=12 Participants
Yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12) and Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet: Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
Control: Yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12)
|
BB-12
n=29 Participants
Bifidobacterium animalis subsp. lactis BB-12 (BB-12)-supplemented yogurt and Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet: Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
BB-12: Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt
|
|---|---|---|
|
Level of Fecal SCFA Propionate
Day 0
|
14.3 μM
Standard Deviation 9.1
|
13.0 μM
Standard Deviation 7.2
|
|
Level of Fecal SCFA Propionate
Day 7
|
14.3 μM
Standard Deviation 6.7
|
12.5 μM
Standard Deviation 6.0
|
|
Level of Fecal SCFA Propionate
Day 14
|
11.8 μM
Standard Deviation 6.9
|
12.0 μM
Standard Deviation 6.1
|
|
Level of Fecal SCFA Propionate
Day 21
|
11.0 μM
Standard Deviation 3.5
|
14.8 μM
Standard Deviation 7.8
|
|
Level of Fecal SCFA Propionate
Day 30
|
11.4 μM
Standard Deviation 7.3
|
11.5 μM
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: day 0 (post run-in), 7, 14, 21, 30Population: Number of samples received
Level of fecal short-chain fatty acid butyrate (μM) after administration of amoxicillin clavulanate
Outcome measures
| Measure |
Control
n=12 Participants
Yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12) and Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet: Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
Control: Yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12)
|
BB-12
n=29 Participants
Bifidobacterium animalis subsp. lactis BB-12 (BB-12)-supplemented yogurt and Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet: Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
BB-12: Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt
|
|---|---|---|
|
Level of Fecal SCFA Butyrate
Day 0
|
12.7 μM
Standard Deviation 6.2
|
12.7 μM
Standard Deviation 8.4
|
|
Level of Fecal SCFA Butyrate
Day 7
|
9.0 μM
Standard Deviation 5.3
|
8.3 μM
Standard Deviation 5.7
|
|
Level of Fecal SCFA Butyrate
Day 14
|
7.4 μM
Standard Deviation 4.3
|
8.9 μM
Standard Deviation 6.1
|
|
Level of Fecal SCFA Butyrate
Day 21
|
11.6 μM
Standard Deviation 9.2
|
11.9 μM
Standard Deviation 7.8
|
|
Level of Fecal SCFA Butyrate
Day 30
|
8.3 μM
Standard Deviation 5.3
|
9.9 μM
Standard Deviation 4.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: day 0 (pre run-in), 7, 14, 21, 30Population: Number of samples received
The Shannon diversity metric is a measure of community diversity and takes into account species richness (number of distinct taxa) and the relative abundance of each taxon. The Shannon diversity index was calculated for samples at each time point from subjects receiving control or BB-12 yogurt. The first of two baseline samples was collected from each subject at the time of enrollment (pre run-in) before a 30-day run-in period in which the consumption of dietary probiotics was stopped. A higher index indicates more diversity and a lower index indicates less diversity.
Outcome measures
| Measure |
Control
n=18 Participants
Yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12) and Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet: Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
Control: Yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12)
|
BB-12
n=38 Participants
Bifidobacterium animalis subsp. lactis BB-12 (BB-12)-supplemented yogurt and Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet: Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
BB-12: Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt
|
|---|---|---|
|
Change in Community Diversity (Shannon Diversity Index) From Pre run-in Baseline
Day 0 Pre run-in
|
3.711 Shannon Diversity Index
Standard Deviation 0.349
|
3.774 Shannon Diversity Index
Standard Deviation 0.302
|
|
Change in Community Diversity (Shannon Diversity Index) From Pre run-in Baseline
Day 7
|
3.380 Shannon Diversity Index
Standard Deviation 0.364
|
3.567 Shannon Diversity Index
Standard Deviation 0.479
|
|
Change in Community Diversity (Shannon Diversity Index) From Pre run-in Baseline
Day 14
|
3.419 Shannon Diversity Index
Standard Deviation 0.465
|
3.632 Shannon Diversity Index
Standard Deviation 0.307
|
|
Change in Community Diversity (Shannon Diversity Index) From Pre run-in Baseline
Day 21
|
3.709 Shannon Diversity Index
Standard Deviation 0.322
|
3.708 Shannon Diversity Index
Standard Deviation 0.308
|
|
Change in Community Diversity (Shannon Diversity Index) From Pre run-in Baseline
Day 30
|
3.395 Shannon Diversity Index
Standard Deviation 0.409
|
3.684 Shannon Diversity Index
Standard Deviation 0.397
|
OTHER_PRE_SPECIFIED outcome
Timeframe: day 0 (post run-in), 7, 14, 21, 30Population: Number of samples received
The Shannon diversity metric is a measure of community diversity and takes into account species richness (number of distinct taxa) and the relative abundance of each taxon. The Shannon diversity index was calculated for samples at each time point from subjects receiving control or BB-12 yogurt. The second baseline sample was collected from each subject after a 30-day run-in period in which the consumption of dietary probiotics was stopped (post run-in). A higher index indicates more diversity and a lower index indicates less diversity.
Outcome measures
| Measure |
Control
n=18 Participants
Yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12) and Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet: Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
Control: Yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12)
|
BB-12
n=38 Participants
Bifidobacterium animalis subsp. lactis BB-12 (BB-12)-supplemented yogurt and Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet: Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
BB-12: Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt
|
|---|---|---|
|
Change in Community Diversity (Shannon Diversity Index) From Post run-in Baseline
Day 0 Post run-in
|
3.845 Shannon Diversity Index
Standard Deviation 0.290
|
3.718 Shannon Diversity Index
Standard Deviation 0.261
|
|
Change in Community Diversity (Shannon Diversity Index) From Post run-in Baseline
Day 7
|
3.528 Shannon Diversity Index
Standard Deviation 0.396
|
3.606 Shannon Diversity Index
Standard Deviation 0.494
|
|
Change in Community Diversity (Shannon Diversity Index) From Post run-in Baseline
Day 14
|
3.496 Shannon Diversity Index
Standard Deviation 0.486
|
3.666 Shannon Diversity Index
Standard Deviation 0.304
|
|
Change in Community Diversity (Shannon Diversity Index) From Post run-in Baseline
Day 21
|
3.785 Shannon Diversity Index
Standard Deviation 0.295
|
3.727 Shannon Diversity Index
Standard Deviation 0.278
|
|
Change in Community Diversity (Shannon Diversity Index) From Post run-in Baseline
Day 30
|
3.486 Shannon Diversity Index
Standard Deviation 0.444
|
3.712 Shannon Diversity Index
Standard Deviation 0.391
|
OTHER_PRE_SPECIFIED outcome
Timeframe: day 0, 7, 14, 21, 30Community divergence over time with respect to the baseline sample (post run-in, day 0)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: day 7, 14, 21, 30Change in diarrhea/stool frequency from baseline
Outcome measures
Outcome data not reported
Adverse Events
Control
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
BB-12
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control
n=18 participants at risk；n=20 participants at risk
Yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12) and Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet: Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
Control: Yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12)
|
BB-12
n=38 participants at risk；n=42 participants at risk
Bifidobacterium animalis subsp. lactis BB-12 (BB-12)-supplemented yogurt and Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet: Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
BB-12: Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt
|
|---|---|---|
|
Gastrointestinal disorders
Loose stool
|
50.0%
9/18 • Pre-run in baseline to day 30
|
36.8%
14/38 • Pre-run in baseline to day 30
|
|
Gastrointestinal disorders
Diarrhea
|
5.6%
1/18 • Pre-run in baseline to day 30
|
2.6%
1/38 • Pre-run in baseline to day 30
|
|
Gastrointestinal disorders
Constipation
|
16.7%
3/18 • Pre-run in baseline to day 30
|
10.5%
4/38 • Pre-run in baseline to day 30
|
|
Gastrointestinal disorders
Flatulence
|
44.4%
8/18 • Pre-run in baseline to day 30
|
21.1%
8/38 • Pre-run in baseline to day 30
|
|
General disorders
Lack/Loss of Appetite
|
16.7%
3/18 • Pre-run in baseline to day 30
|
5.3%
2/38 • Pre-run in baseline to day 30
|
|
Gastrointestinal disorders
Stomach Pain
|
16.7%
3/18 • Pre-run in baseline to day 30
|
2.6%
1/38 • Pre-run in baseline to day 30
|
|
General disorders
Rash
|
0.00%
0/18 • Pre-run in baseline to day 30
|
5.3%
2/38 • Pre-run in baseline to day 30
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/18 • Pre-run in baseline to day 30
|
5.3%
2/38 • Pre-run in baseline to day 30
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
3/18 • Pre-run in baseline to day 30
|
2.6%
1/38 • Pre-run in baseline to day 30
|
|
General disorders
Nausea
|
27.8%
5/18 • Pre-run in baseline to day 30
|
7.9%
3/38 • Pre-run in baseline to day 30
|
|
General disorders
Other
|
33.3%
6/18 • Pre-run in baseline to day 30
|
18.4%
7/38 • Pre-run in baseline to day 30
|
Additional Information
Daniel Merenstein, MD
Department of Family Medicine, Georgetown University Medical Center
Phone: 202-687-2745
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place