Trial Outcomes & Findings for Mechanisms of Probiotics and Antibiotic-Associated Diarrhea (NCT NCT04414722)
NCT ID: NCT04414722
Last Updated: 2025-02-25
Results Overview
Change from baseline levels of fecal short-chain fatty acid (with a particular focus on acetate)
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
118 participants
Primary outcome timeframe
day 7
Results posted on
2025-02-25
Participant Flow
After enrollment, participants complete a 30-day run-in during which they refrain from probiotics and antibiotics. Participants who start/experience an exclusionary medication or nontransient health condition during run-in are withdrawn. Participants who take antibiotics during the run-in will delay the initiation of interventions until a full 30-day run-in cycle is complete. Participants who take non-study probiotics will document use and may continue with group assignment.
Participant milestones
| Measure |
Concurrent BB-12 Yogurt and Amoxicillin-clavulanate
Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt and amoxicillin-clavulanate 875 mg-125 mg oral tablet, taken at the same time
|
BB-12 Yogurt Taken 4 Hours After Amoxicillin-clavulanate
Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt taken 4 hours after amoxicillin-clavulanate 875 mg-125 mg oral tablet
|
Concurrent Control Yogurt and Amoxicillin-clavulanate
Control yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12) and amoxicillin-clavulanate 875 mg-125 mg oral tablet, taken at the same time
|
Control Yogurt Taken 4 Hours After Amoxicillin-clavulanate
Control yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12) taken 4 hours after amoxicillin-clavulanate 875 mg-125 mg oral tablet
|
Amoxicillin-clavulanate
Amoxicillin-clavulanate 875 mg-125 mg oral tablet
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
26
|
27
|
26
|
27
|
12
|
|
Overall Study
COMPLETED
|
17
|
18
|
19
|
20
|
8
|
|
Overall Study
NOT COMPLETED
|
9
|
9
|
7
|
7
|
4
|
Reasons for withdrawal
| Measure |
Concurrent BB-12 Yogurt and Amoxicillin-clavulanate
Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt and amoxicillin-clavulanate 875 mg-125 mg oral tablet, taken at the same time
|
BB-12 Yogurt Taken 4 Hours After Amoxicillin-clavulanate
Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt taken 4 hours after amoxicillin-clavulanate 875 mg-125 mg oral tablet
|
Concurrent Control Yogurt and Amoxicillin-clavulanate
Control yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12) and amoxicillin-clavulanate 875 mg-125 mg oral tablet, taken at the same time
|
Control Yogurt Taken 4 Hours After Amoxicillin-clavulanate
Control yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12) taken 4 hours after amoxicillin-clavulanate 875 mg-125 mg oral tablet
|
Amoxicillin-clavulanate
Amoxicillin-clavulanate 875 mg-125 mg oral tablet
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
3
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
6
|
3
|
1
|
5
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
2
|
0
|
0
|
|
Overall Study
Non-participatory
|
0
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Mechanisms of Probiotics and Antibiotic-Associated Diarrhea
Baseline characteristics by cohort
| Measure |
Concurrent BB-12 Yogurt and Amoxicillin-clavulanate
n=26 Participants
Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt and amoxicillin-clavulanate 875 mg-125 mg oral tablet, taken at the same time
|
BB-12 Yogurt Taken 4 Hours After Amoxicillin-clavulanate
n=27 Participants
Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt taken 4 hours after amoxicillin-clavulanate 875 mg-125 mg oral tablet
|
Concurrent Control Yogurt and Amoxicillin-clavulanate
n=26 Participants
Control yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12) and amoxicillin-clavulanate 875 mg-125 mg oral tablet, taken at the same time
|
Control Yogurt Taken 4 Hours After Amoxicillin-clavulanate
n=27 Participants
Control yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12) taken 4 hours after amoxicillin-clavulanate 875 mg-125 mg oral tablet
|
Amoxicillin-clavulanate
n=12 Participants
Amoxicillin-clavulanate 875 mg-125 mg oral tablet
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
28.15 years
STANDARD_DEVIATION 13.86 • n=5 Participants
|
33.88 years
STANDARD_DEVIATION 14.79 • n=7 Participants
|
30.18 years
STANDARD_DEVIATION 11.95 • n=5 Participants
|
31.95 years
STANDARD_DEVIATION 14.09 • n=4 Participants
|
26.30 years
STANDARD_DEVIATION 7.78 • n=21 Participants
|
30.47 years
STANDARD_DEVIATION 2.998 • n=8 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
71 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
47 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
101 Participants
n=8 Participants
|
|
Ethnicity (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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
74 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: day 7Population: Participants were required to have baseline and Day 7 samples in order for this measurement to be taken. Participants that were not analyzed were missing a baseline or Day 7 comparator therefore were not analyzed.
Change from baseline levels of fecal short-chain fatty acid (with a particular focus on acetate)
Outcome measures
| Measure |
Concurrent BB-12 Yogurt and Amoxicillin-clavulanate
n=12 Participants
Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt and amoxicillin-clavulanate 875 mg-125 mg oral tablet, taken at the same time
|
BB-12 Yogurt Taken 4 Hours After Amoxicillin-clavulanate
n=13 Participants
Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt taken 4 hours after amoxicillin-clavulanate 875 mg-125 mg oral tablet
|
Concurrent Control Yogurt and Amoxicillin-clavulanate
n=11 Participants
Control yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12) and amoxicillin-clavulanate 875 mg-125 mg oral tablet, taken at the same time
|
Control Yogurt Taken 4 Hours After Amoxicillin-clavulanate
n=14 Participants
Control yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12) taken 4 hours after amoxicillin-clavulanate 875 mg-125 mg oral tablet
|
Amoxicillin-clavulanate
n=6 Participants
Amoxicillin-clavulanate 875 mg-125 mg oral tablet
|
|---|---|---|---|---|---|
|
Change From Baseline Levels of Fecal Short-chain Fatty Acid (With a Particular Focus on Acetate)
|
23.55 micromolar
Interval -51.55 to 78.8
|
-13.9 micromolar
Interval -30.1 to 24.7
|
-19.5 micromolar
Interval -41.1 to -8.3
|
7.25 micromolar
Interval -51.2 to 31.1
|
-21.7 micromolar
Interval -34.6 to -4.0
|
PRIMARY outcome
Timeframe: day 30Population: Participants were required to have baseline and Day 30 samples in order for this measurement to be taken. Participants that were not analyzed were missing a baseline or Day 30 comparator therefore were not analyzed.
Change from baseline levels of fecal short-chain fatty acid (with a particular focus on acetate)
Outcome measures
| Measure |
Concurrent BB-12 Yogurt and Amoxicillin-clavulanate
n=10 Participants
Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt and amoxicillin-clavulanate 875 mg-125 mg oral tablet, taken at the same time
|
BB-12 Yogurt Taken 4 Hours After Amoxicillin-clavulanate
n=12 Participants
Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt taken 4 hours after amoxicillin-clavulanate 875 mg-125 mg oral tablet
|
Concurrent Control Yogurt and Amoxicillin-clavulanate
n=8 Participants
Control yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12) and amoxicillin-clavulanate 875 mg-125 mg oral tablet, taken at the same time
|
Control Yogurt Taken 4 Hours After Amoxicillin-clavulanate
n=11 Participants
Control yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12) taken 4 hours after amoxicillin-clavulanate 875 mg-125 mg oral tablet
|
Amoxicillin-clavulanate
n=6 Participants
Amoxicillin-clavulanate 875 mg-125 mg oral tablet
|
|---|---|---|---|---|---|
|
Change From Baseline Levels of Fecal Short-chain Fatty Acid (With a Particular Focus on Acetate)
|
2.5 micromolar
Interval -44.7 to 26.4
|
7.8 micromolar
Interval -16.9 to 69.4
|
6.1 micromolar
Interval -46.3 to 20.4
|
-25.5 micromolar
Interval -41.8 to 36.6
|
-15.75 micromolar
Interval -30.7 to 59.7
|
SECONDARY outcome
Timeframe: day 7Population: Participants were required to have baseline and Day 7 samples in order for this measurement to be taken. Participants that were not analyzed were missing a baseline or Day 7 comparator therefore were not analyzed.
Percentage Change in Baseline Diversity of Bacterial Species in Fecal Microbiota (based on the Shannon Diversity Index, percentage of change): This outcome measures the percentage change in baseline diversity of bacterial species in the fecal microbiota, using the Shannon Diversity Index. Percent change within each treatment group was calculated comparing the Shannon diversity index at each follow-up day (i.e., day 7) to day 0 (baseline). The Shannon Diversity Index is a commonly used method to quantify microbial diversity, incorporating both the richness (the number of different species) and evenness (the distribution of species) within a sample. A positive percentage change reflects an increase in microbial diversity, while a negative percentage change indicates a decrease in microbial diversity compared to the microbial diversity at baseline.
Outcome measures
| Measure |
Concurrent BB-12 Yogurt and Amoxicillin-clavulanate
n=17 Participants
Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt and amoxicillin-clavulanate 875 mg-125 mg oral tablet, taken at the same time
|
BB-12 Yogurt Taken 4 Hours After Amoxicillin-clavulanate
n=12 Participants
Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt taken 4 hours after amoxicillin-clavulanate 875 mg-125 mg oral tablet
|
Concurrent Control Yogurt and Amoxicillin-clavulanate
n=17 Participants
Control yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12) and amoxicillin-clavulanate 875 mg-125 mg oral tablet, taken at the same time
|
Control Yogurt Taken 4 Hours After Amoxicillin-clavulanate
n=18 Participants
Control yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12) taken 4 hours after amoxicillin-clavulanate 875 mg-125 mg oral tablet
|
Amoxicillin-clavulanate
n=7 Participants
Amoxicillin-clavulanate 875 mg-125 mg oral tablet
|
|---|---|---|---|---|---|
|
Percentage Change in Baseline Diversity of Bacterial Species in Fecal Microbiota
|
-8.062 percentage of change
Standard Deviation 17.52
|
-8.994 percentage of change
Standard Deviation 11.511
|
-16.177 percentage of change
Standard Deviation 16.053
|
-13.479 percentage of change
Standard Deviation 17.7
|
-4.614 percentage of change
Standard Deviation 9.691
|
SECONDARY outcome
Timeframe: day 14Population: Participants were required to have baseline and Day 14 samples in order for this measurement to be taken. Participants that were not analyzed were missing a baseline or Day 14 comparator therefore were not analyzed.
Percentage Change in Baseline Diversity of Bacterial Species in Fecal Microbiota (based on the Shannon Diversity Index, percentage of change): This outcome measures the percentage change in baseline diversity of bacterial species in the fecal microbiota, using the Shannon Diversity Index. Percent change within each treatment group was calculated comparing the Shannon diversity index at each follow-up day (i.e., day 14) to day 0 (baseline). The Shannon Diversity Index is a commonly used method to quantify microbial diversity, incorporating both the richness (the number of different species) and evenness (the distribution of species) within a sample. A positive percentage change reflects an increase in microbial diversity, while a negative percentage change indicates a decrease in microbial diversity compared to the microbial diversity at baseline.
Outcome measures
| Measure |
Concurrent BB-12 Yogurt and Amoxicillin-clavulanate
n=15 Participants
Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt and amoxicillin-clavulanate 875 mg-125 mg oral tablet, taken at the same time
|
BB-12 Yogurt Taken 4 Hours After Amoxicillin-clavulanate
n=17 Participants
Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt taken 4 hours after amoxicillin-clavulanate 875 mg-125 mg oral tablet
|
Concurrent Control Yogurt and Amoxicillin-clavulanate
n=17 Participants
Control yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12) and amoxicillin-clavulanate 875 mg-125 mg oral tablet, taken at the same time
|
Control Yogurt Taken 4 Hours After Amoxicillin-clavulanate
n=17 Participants
Control yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12) taken 4 hours after amoxicillin-clavulanate 875 mg-125 mg oral tablet
|
Amoxicillin-clavulanate
n=7 Participants
Amoxicillin-clavulanate 875 mg-125 mg oral tablet
|
|---|---|---|---|---|---|
|
Percentage Change in Baseline Diversity of Bacterial Species in Fecal Microbiota
|
-1.456 percentage of change
Standard Deviation 12.013
|
-1.826 percentage of change
Standard Deviation 10.395
|
-5.999 percentage of change
Standard Deviation 13.018
|
-7.547 percentage of change
Standard Deviation 10.808
|
-2.374 percentage of change
Standard Deviation 7.471
|
OTHER_PRE_SPECIFIED outcome
Timeframe: day 14Population: Participants were required to have baseline and Day 14 samples in order for this measurement to be taken. Participants that were not analyzed were missing a baseline or Day 14 comparator therefore were not analyzed.
Change from baseline levels of fecal short-chain fatty acid (with a particular focus on acetate)
Outcome measures
| Measure |
Concurrent BB-12 Yogurt and Amoxicillin-clavulanate
n=11 Participants
Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt and amoxicillin-clavulanate 875 mg-125 mg oral tablet, taken at the same time
|
BB-12 Yogurt Taken 4 Hours After Amoxicillin-clavulanate
n=12 Participants
Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt taken 4 hours after amoxicillin-clavulanate 875 mg-125 mg oral tablet
|
Concurrent Control Yogurt and Amoxicillin-clavulanate
n=11 Participants
Control yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12) and amoxicillin-clavulanate 875 mg-125 mg oral tablet, taken at the same time
|
Control Yogurt Taken 4 Hours After Amoxicillin-clavulanate
n=14 Participants
Control yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12) taken 4 hours after amoxicillin-clavulanate 875 mg-125 mg oral tablet
|
Amoxicillin-clavulanate
n=6 Participants
Amoxicillin-clavulanate 875 mg-125 mg oral tablet
|
|---|---|---|---|---|---|
|
Change From Baseline Levels of Fecal Short-chain Fatty Acid (With a Particular Focus on Acetate)
|
1.6 micromolar
Interval -24.5 to 66.3
|
0.6 micromolar
Interval -10.1 to 63.0
|
-37.8 micromolar
Interval -53.0 to 23.6
|
-13 micromolar
Interval -36.6 to 29.9
|
-5.3 micromolar
Interval -31.2 to 23.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: day 21Population: Participants were required to have baseline and Day 21 samples in order for this measurement to be taken. Participants that were not analyzed were missing a baseline or Day 21 comparator therefore were not analyzed.
Change from baseline levels of fecal short-chain fatty acid (with a particular focus on acetate)
Outcome measures
| Measure |
Concurrent BB-12 Yogurt and Amoxicillin-clavulanate
n=12 Participants
Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt and amoxicillin-clavulanate 875 mg-125 mg oral tablet, taken at the same time
|
BB-12 Yogurt Taken 4 Hours After Amoxicillin-clavulanate
n=12 Participants
Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt taken 4 hours after amoxicillin-clavulanate 875 mg-125 mg oral tablet
|
Concurrent Control Yogurt and Amoxicillin-clavulanate
n=10 Participants
Control yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12) and amoxicillin-clavulanate 875 mg-125 mg oral tablet, taken at the same time
|
Control Yogurt Taken 4 Hours After Amoxicillin-clavulanate
n=13 Participants
Control yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12) taken 4 hours after amoxicillin-clavulanate 875 mg-125 mg oral tablet
|
Amoxicillin-clavulanate
n=4 Participants
Amoxicillin-clavulanate 875 mg-125 mg oral tablet
|
|---|---|---|---|---|---|
|
Change From Baseline Levels of Fecal Short-chain Fatty Acid (With a Particular Focus on Acetate)
|
-25.65 micromolar
Interval -37.7 to 67.2
|
-10.75 micromolar
Interval -46.6 to 27.7
|
-21.3 micromolar
Interval -47.3 to -5.3
|
-18.2 micromolar
Interval -41.7 to 24.4
|
-5.7 micromolar
Interval -39.3 to 0.3
|
Adverse Events
Concurrent BB-12 Yogurt and Amoxicillin-clavulanate
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
BB-12 Yogurt Taken 4 Hours After Amoxicillin-clavulanate
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Concurrent Control Yogurt and Amoxicillin-clavulanate
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Control Yogurt Taken 4 Hours After Amoxicillin-clavulanate
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Amoxicillin-clavulanate
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Concurrent BB-12 Yogurt and Amoxicillin-clavulanate
n=26 participants at risk
Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt and amoxicillin-clavulanate 875 mg-125 mg oral tablet, taken at the same time
|
BB-12 Yogurt Taken 4 Hours After Amoxicillin-clavulanate
n=27 participants at risk
Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt taken 4 hours after amoxicillin-clavulanate 875 mg-125 mg oral tablet
|
Concurrent Control Yogurt and Amoxicillin-clavulanate
n=26 participants at risk
Control yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12) and amoxicillin-clavulanate 875 mg-125 mg oral tablet, taken at the same time
|
Control Yogurt Taken 4 Hours After Amoxicillin-clavulanate
n=27 participants at risk
Control yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12) taken 4 hours after amoxicillin-clavulanate 875 mg-125 mg oral tablet
|
Amoxicillin-clavulanate
n=12 participants at risk
Amoxicillin-clavulanate 875 mg-125 mg oral tablet
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/26 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
0.00%
0/27 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
3.8%
1/26 • Number of events 1 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
0.00%
0/27 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
0.00%
0/12 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
Other adverse events
| Measure |
Concurrent BB-12 Yogurt and Amoxicillin-clavulanate
n=26 participants at risk
Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt and amoxicillin-clavulanate 875 mg-125 mg oral tablet, taken at the same time
|
BB-12 Yogurt Taken 4 Hours After Amoxicillin-clavulanate
n=27 participants at risk
Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt taken 4 hours after amoxicillin-clavulanate 875 mg-125 mg oral tablet
|
Concurrent Control Yogurt and Amoxicillin-clavulanate
n=26 participants at risk
Control yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12) and amoxicillin-clavulanate 875 mg-125 mg oral tablet, taken at the same time
|
Control Yogurt Taken 4 Hours After Amoxicillin-clavulanate
n=27 participants at risk
Control yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12) taken 4 hours after amoxicillin-clavulanate 875 mg-125 mg oral tablet
|
Amoxicillin-clavulanate
n=12 participants at risk
Amoxicillin-clavulanate 875 mg-125 mg oral tablet
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Flatulence
|
26.9%
7/26 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
29.6%
8/27 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
30.8%
8/26 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
22.2%
6/27 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
33.3%
4/12 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
|
Gastrointestinal disorders
Stomach pain
|
19.2%
5/26 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
29.6%
8/27 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
19.2%
5/26 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
22.2%
6/27 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
16.7%
2/12 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
|
Gastrointestinal disorders
Constipation
|
23.1%
6/26 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
18.5%
5/27 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
15.4%
4/26 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
14.8%
4/27 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
8.3%
1/12 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
|
Gastrointestinal disorders
Dyspepsia
|
7.7%
2/26 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
18.5%
5/27 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
11.5%
3/26 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
7.4%
2/27 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
16.7%
2/12 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
|
General disorders
Fever
|
0.00%
0/26 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
7.4%
2/27 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
3.8%
1/26 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
0.00%
0/27 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
0.00%
0/12 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
|
Gastrointestinal disorders
Lack/loss of appetite
|
7.7%
2/26 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
11.1%
3/27 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
15.4%
4/26 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
7.4%
2/27 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
0.00%
0/12 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
|
General disorders
Rash
|
0.00%
0/26 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
3.7%
1/27 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
0.00%
0/26 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
3.7%
1/27 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
0.00%
0/12 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
|
Gastrointestinal disorders
Loose stools
|
26.9%
7/26 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
44.4%
12/27 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
46.2%
12/26 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
33.3%
9/27 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
25.0%
3/12 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/26 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
0.00%
0/27 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
7.7%
2/26 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
0.00%
0/27 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
0.00%
0/12 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
|
Gastrointestinal disorders
Nausea
|
11.5%
3/26 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
11.1%
3/27 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
0.00%
0/26 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
14.8%
4/27 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
8.3%
1/12 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
|
Nervous system disorders
Migraine
|
0.00%
0/26 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
0.00%
0/27 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
0.00%
0/26 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
3.7%
1/27 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
0.00%
0/12 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
|
Nervous system disorders
Headache
|
0.00%
0/26 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
0.00%
0/27 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
3.8%
1/26 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
7.4%
2/27 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
0.00%
0/12 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
|
General disorders
Dryness of back of throat and tongue
|
0.00%
0/26 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
0.00%
0/27 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
0.00%
0/26 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
0.00%
0/27 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
8.3%
1/12 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
|
General disorders
Cramps
|
0.00%
0/26 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
0.00%
0/27 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
0.00%
0/26 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
7.4%
2/27 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
0.00%
0/12 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.00%
0/26 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
0.00%
0/27 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
3.8%
1/26 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
0.00%
0/27 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
0.00%
0/12 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/26 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
0.00%
0/27 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
0.00%
0/26 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
3.7%
1/27 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
0.00%
0/12 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/26 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
0.00%
0/27 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
0.00%
0/26 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
3.7%
1/27 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
0.00%
0/12 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
|
Respiratory, thoracic and mediastinal disorders
Seasonal allergies
|
0.00%
0/26 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
0.00%
0/27 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
0.00%
0/26 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
3.7%
1/27 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
0.00%
0/12 • From baseline, through the 30-day run-in, and 30 days on-study (total 2 months)
|
Additional Information
Dan Merenstein, Director of Research Programs
Dept. of Family Medicine, Georgetown University Medical Center
Phone: 202-687-1600
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place