Trial Outcomes & Findings for Effects of Pre-, Pro- & Anti-biotics on Gut Microbiota (NCT NCT01414010)
NCT ID: NCT01414010
Last Updated: 2017-07-24
Results Overview
The most prevalent bacterial genera within the study population Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Days 10 and 14 After Treatment: Average of Days 21, 28, and 56
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
Day 0 to 56
Results posted on
2017-07-24
Participant Flow
Participant milestones
| Measure |
Prebiotic
Trametes versicolor extract: 1,200 mg, 3 times daily on an empty stomach for 14 days
|
Probiotic
Saccharomyces boulardii: 250 mg, 3 times daily on an empty stomach for 14 days
|
Antibiotic
Amoxicillin: 250 mg 3 times daily at least 1 hour before meals for 7 days
|
Control
Control group, no intervention given.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
6
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Pre-, Pro- & Anti-biotics on Gut Microbiota
Baseline characteristics by cohort
| Measure |
Prebiotic
n=8 Participants
Trametes versicolor extract: 1,200 mg, 3 times daily on an empty stomach for 14 days
|
Probiotic
n=8 Participants
Saccharomyces boulardii: 250 mg, 3 times daily on an empty stomach for 14 days
|
Antibiotic
n=8 Participants
Amoxicillin: 250 mg 3 times daily at least 1 hour before meals for 7 days
|
Control
n=8 Participants
Control group, no intervention given.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
33.5 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
32.9 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
32.1 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
29.9 years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
32 years
STANDARD_DEVIATION 10.1 • n=21 Participants
|
|
Age, Categorical
<=18 years
|
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
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
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
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
8 participants
n=4 Participants
|
32 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 0 to 56Population: The investigators expanded their studies on the probiotic (Saccharomyces boulardii) to constitute a full, separate study. Reference: NCT01473368.
The most prevalent bacterial genera within the study population Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Days 10 and 14 After Treatment: Average of Days 21, 28, and 56
Outcome measures
| Measure |
Amoxicillin - Before Treatment
n=8 Participants
Amoxicillin: 250 mg 3 times daily at least 1 hour before meals for 7 days
|
Amoxicillin - During Treatment
n=8 Participants
Amoxicillin: 250 mg 3 times daily at least 1 hour before meals for 7 days
|
Amoxicillin - After Treatment
n=8 Participants
Amoxicillin: 250 mg 3 times daily at least 1 hour before meals for 7 days
|
Control
n=8 Participants
Control group - no intervention given.
|
Trametes Versicolor Extract - Before Treatment
n=6 Participants
Trametes versicolor extract: 1,200 mg, 3 times daily on an empty stomach for 14 days
|
Trametes Versicolor Extract - During Treatment
n=6 Participants
Trametes versicolor extract: 1,200 mg, 3 times daily on an empty stomach for 14 days
|
Trametes Versicolor Extract - After Treatment
n=6 Participants
Trametes versicolor extract: 1,200 mg, 3 times daily on an empty stomach for 14 days
|
Saccharomyces Boulardii - Before Treatment
n=7 Participants
Saccharomyces boulardii: 250 mg, 3 times daily on an empty stomach for 14 days
|
Saccharomyces Boulardii - During Treatment
n=7 Participants
Saccharomyces boulardii: 250 mg, 3 times daily on an empty stomach for 14 days
|
Saccharomyces Boulardii - After Treatment
n=7 Participants
Saccharomyces boulardii: 250 mg, 3 times daily on an empty stomach for 14 days
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Bacteria Prevalence in Stool
Faecalibacterium
|
22.3 percentage of bacterial genera in stool
Standard Deviation 0
|
20.9 percentage of bacterial genera in stool
Standard Deviation 0
|
18.0 percentage of bacterial genera in stool
Standard Deviation 0
|
25.5 percentage of bacterial genera in stool
Standard Deviation 0
|
12.7 percentage of bacterial genera in stool
Standard Deviation 0
|
22.6 percentage of bacterial genera in stool
Standard Deviation 0
|
12.6 percentage of bacterial genera in stool
Standard Deviation 0
|
19.3 percentage of bacterial genera in stool
Standard Deviation 0
|
25.2 percentage of bacterial genera in stool
Standard Deviation 0
|
21.2 percentage of bacterial genera in stool
Standard Deviation 0
|
|
Bacteria Prevalence in Stool
Bacteroides
|
13.9 percentage of bacterial genera in stool
Standard Deviation 0
|
17.9 percentage of bacterial genera in stool
Standard Deviation 0
|
17.3 percentage of bacterial genera in stool
Standard Deviation 0
|
22.3 percentage of bacterial genera in stool
Standard Deviation 0
|
23.6 percentage of bacterial genera in stool
Standard Deviation 0
|
17.6 percentage of bacterial genera in stool
Standard Deviation 0
|
21.8 percentage of bacterial genera in stool
Standard Deviation 0
|
12.6 percentage of bacterial genera in stool
Standard Deviation 0
|
10.8 percentage of bacterial genera in stool
Standard Deviation 0
|
16.6 percentage of bacterial genera in stool
Standard Deviation 0
|
|
Bacteria Prevalence in Stool
Roseburia
|
12.6 percentage of bacterial genera in stool
Standard Deviation 0
|
6.1 percentage of bacterial genera in stool
Standard Deviation 0
|
10.2 percentage of bacterial genera in stool
Standard Deviation 0
|
9.1 percentage of bacterial genera in stool
Standard Deviation 0
|
8.6 percentage of bacterial genera in stool
Standard Deviation 0
|
11.4 percentage of bacterial genera in stool
Standard Deviation 0
|
15.1 percentage of bacterial genera in stool
Standard Deviation 0
|
7.3 percentage of bacterial genera in stool
Standard Deviation 0
|
6.2 percentage of bacterial genera in stool
Standard Deviation 0
|
7.3 percentage of bacterial genera in stool
Standard Deviation 0
|
|
Bacteria Prevalence in Stool
Clostridium
|
7.9 percentage of bacterial genera in stool
Standard Deviation 0
|
9.9 percentage of bacterial genera in stool
Standard Deviation 0
|
9.4 percentage of bacterial genera in stool
Standard Deviation 0
|
6.4 percentage of bacterial genera in stool
Standard Deviation 0
|
11.3 percentage of bacterial genera in stool
Standard Deviation 0
|
8.0 percentage of bacterial genera in stool
Standard Deviation 0
|
12.1 percentage of bacterial genera in stool
Standard Deviation 0
|
10.6 percentage of bacterial genera in stool
Standard Deviation 0
|
10.9 percentage of bacterial genera in stool
Standard Deviation 0
|
10.5 percentage of bacterial genera in stool
Standard Deviation 0
|
|
Bacteria Prevalence in Stool
Oscillospira
|
10.4 percentage of bacterial genera in stool
Standard Deviation 0
|
6.3 percentage of bacterial genera in stool
Standard Deviation 0
|
7.2 percentage of bacterial genera in stool
Standard Deviation 0
|
5.8 percentage of bacterial genera in stool
Standard Deviation 0
|
7.1 percentage of bacterial genera in stool
Standard Deviation 0
|
7.0 percentage of bacterial genera in stool
Standard Deviation 0
|
7.8 percentage of bacterial genera in stool
Standard Deviation 0
|
2.0 percentage of bacterial genera in stool
Standard Deviation 0
|
2.1 percentage of bacterial genera in stool
Standard Deviation 0
|
2.2 percentage of bacterial genera in stool
Standard Deviation 0
|
|
Bacteria Prevalence in Stool
Dialister
|
8.2 percentage of bacterial genera in stool
Standard Deviation 0
|
2.5 percentage of bacterial genera in stool
Standard Deviation 0
|
8.8 percentage of bacterial genera in stool
Standard Deviation 0
|
9.0 percentage of bacterial genera in stool
Standard Deviation 0
|
6.6 percentage of bacterial genera in stool
Standard Deviation 0
|
7.3 percentage of bacterial genera in stool
Standard Deviation 0
|
5.4 percentage of bacterial genera in stool
Standard Deviation 0
|
12.2 percentage of bacterial genera in stool
Standard Deviation 0
|
14.3 percentage of bacterial genera in stool
Standard Deviation 0
|
11.4 percentage of bacterial genera in stool
Standard Deviation 0
|
|
Bacteria Prevalence in Stool
Ruminococcus
|
5.1 percentage of bacterial genera in stool
Standard Deviation 0
|
3.2 percentage of bacterial genera in stool
Standard Deviation 0
|
4.0 percentage of bacterial genera in stool
Standard Deviation 0
|
3.8 percentage of bacterial genera in stool
Standard Deviation 0
|
6.4 percentage of bacterial genera in stool
Standard Deviation 0
|
6.6 percentage of bacterial genera in stool
Standard Deviation 0
|
4.8 percentage of bacterial genera in stool
Standard Deviation 0
|
3.7 percentage of bacterial genera in stool
Standard Deviation 0
|
5.9 percentage of bacterial genera in stool
Standard Deviation 0
|
5.0 percentage of bacterial genera in stool
Standard Deviation 0
|
|
Bacteria Prevalence in Stool
Coprococcus
|
3.1 percentage of bacterial genera in stool
Standard Deviation 0
|
1.8 percentage of bacterial genera in stool
Standard Deviation 0
|
4.0 percentage of bacterial genera in stool
Standard Deviation 0
|
1.8 percentage of bacterial genera in stool
Standard Deviation 0
|
2.8 percentage of bacterial genera in stool
Standard Deviation 0
|
1.8 percentage of bacterial genera in stool
Standard Deviation 0
|
1.8 percentage of bacterial genera in stool
Standard Deviation 0
|
1.9 percentage of bacterial genera in stool
Standard Deviation 0
|
2.2 percentage of bacterial genera in stool
Standard Deviation 0
|
2.9 percentage of bacterial genera in stool
Standard Deviation 0
|
|
Bacteria Prevalence in Stool
Prevotella
|
1.8 percentage of bacterial genera in stool
Standard Deviation 0
|
3.7 percentage of bacterial genera in stool
Standard Deviation 0
|
4.8 percentage of bacterial genera in stool
Standard Deviation 0
|
2.7 percentage of bacterial genera in stool
Standard Deviation 0
|
0.9 percentage of bacterial genera in stool
Standard Deviation 0
|
0.3 percentage of bacterial genera in stool
Standard Deviation 0
|
0.4 percentage of bacterial genera in stool
Standard Deviation 0
|
2.7 percentage of bacterial genera in stool
Standard Deviation 0
|
1.0 percentage of bacterial genera in stool
Standard Deviation 0
|
1.3 percentage of bacterial genera in stool
Standard Deviation 0
|
|
Bacteria Prevalence in Stool
Blautia
|
2.3 percentage of bacterial genera in stool
Standard Deviation 0
|
1.3 percentage of bacterial genera in stool
Standard Deviation 0
|
1.5 percentage of bacterial genera in stool
Standard Deviation 0
|
1.9 percentage of bacterial genera in stool
Standard Deviation 0
|
2.6 percentage of bacterial genera in stool
Standard Deviation 0
|
2.5 percentage of bacterial genera in stool
Standard Deviation 0
|
4.4 percentage of bacterial genera in stool
Standard Deviation 0
|
1.6 percentage of bacterial genera in stool
Standard Deviation 0
|
1.9 percentage of bacterial genera in stool
Standard Deviation 0
|
2.4 percentage of bacterial genera in stool
Standard Deviation 0
|
|
Bacteria Prevalence in Stool
Escherichia/shigella
|
1.2 percentage of bacterial genera in stool
Standard Deviation 0
|
14.8 percentage of bacterial genera in stool
Standard Deviation 0
|
3.0 percentage of bacterial genera in stool
Standard Deviation 0
|
1.5 percentage of bacterial genera in stool
Standard Deviation 0
|
0.5 percentage of bacterial genera in stool
Standard Deviation 0
|
0.2 percentage of bacterial genera in stool
Standard Deviation 0
|
1.0 percentage of bacterial genera in stool
Standard Deviation 0
|
0.9 percentage of bacterial genera in stool
Standard Deviation 0
|
0.3 percentage of bacterial genera in stool
Standard Deviation 0
|
0.3 percentage of bacterial genera in stool
Standard Deviation 0
|
|
Bacteria Prevalence in Stool
Phascolarctobacterium
|
1.6 percentage of bacterial genera in stool
Standard Deviation 0
|
1.2 percentage of bacterial genera in stool
Standard Deviation 0
|
1.4 percentage of bacterial genera in stool
Standard Deviation 0
|
1.6 percentage of bacterial genera in stool
Standard Deviation 0
|
1.7 percentage of bacterial genera in stool
Standard Deviation 0
|
2.0 percentage of bacterial genera in stool
Standard Deviation 0
|
1.5 percentage of bacterial genera in stool
Standard Deviation 0
|
2.4 percentage of bacterial genera in stool
Standard Deviation 0
|
2.2 percentage of bacterial genera in stool
Standard Deviation 0
|
2.6 percentage of bacterial genera in stool
Standard Deviation 0
|
|
Bacteria Prevalence in Stool
Alistipes
|
1.4 percentage of bacterial genera in stool
Standard Deviation 0
|
1.0 percentage of bacterial genera in stool
Standard Deviation 0
|
1.1 percentage of bacterial genera in stool
Standard Deviation 0
|
1.1 percentage of bacterial genera in stool
Standard Deviation 0
|
0.8 percentage of bacterial genera in stool
Standard Deviation 0
|
1.4 percentage of bacterial genera in stool
Standard Deviation 0
|
1.0 percentage of bacterial genera in stool
Standard Deviation 0
|
0.5 percentage of bacterial genera in stool
Standard Deviation 0
|
0.6 percentage of bacterial genera in stool
Standard Deviation 0
|
1.1 percentage of bacterial genera in stool
Standard Deviation 0
|
|
Bacteria Prevalence in Stool
Anaerotruncus
|
0.6 percentage of bacterial genera in stool
Standard Deviation 0
|
0.4 percentage of bacterial genera in stool
Standard Deviation 0
|
0.6 percentage of bacterial genera in stool
Standard Deviation 0
|
0.9 percentage of bacterial genera in stool
Standard Deviation 0
|
1.4 percentage of bacterial genera in stool
Standard Deviation 0
|
1.6 percentage of bacterial genera in stool
Standard Deviation 0
|
2.0 percentage of bacterial genera in stool
Standard Deviation 0
|
0.8 percentage of bacterial genera in stool
Standard Deviation 0
|
0.8 percentage of bacterial genera in stool
Standard Deviation 0
|
0.6 percentage of bacterial genera in stool
Standard Deviation 0
|
|
Bacteria Prevalence in Stool
Parabacteroides
|
0.7 percentage of bacterial genera in stool
Standard Deviation 0
|
1.1 percentage of bacterial genera in stool
Standard Deviation 0
|
1.8 percentage of bacterial genera in stool
Standard Deviation 0
|
1.1 percentage of bacterial genera in stool
Standard Deviation 0
|
0.7 percentage of bacterial genera in stool
Standard Deviation 0
|
0.5 percentage of bacterial genera in stool
Standard Deviation 0
|
0.4 percentage of bacterial genera in stool
Standard Deviation 0
|
2.5 percentage of bacterial genera in stool
Standard Deviation 0
|
0.5 percentage of bacterial genera in stool
Standard Deviation 0
|
1.0 percentage of bacterial genera in stool
Standard Deviation 0
|
|
Bacteria Prevalence in Stool
Akkermansia
|
0.1 percentage of bacterial genera in stool
Standard Deviation 0
|
0.2 percentage of bacterial genera in stool
Standard Deviation 0
|
0.7 percentage of bacterial genera in stool
Standard Deviation 0
|
1.1 percentage of bacterial genera in stool
Standard Deviation 0
|
2.1 percentage of bacterial genera in stool
Standard Deviation 0
|
0.3 percentage of bacterial genera in stool
Standard Deviation 0
|
1.5 percentage of bacterial genera in stool
Standard Deviation 0
|
0.9 percentage of bacterial genera in stool
Standard Deviation 0
|
0.2 percentage of bacterial genera in stool
Standard Deviation 0
|
0.7 percentage of bacterial genera in stool
Standard Deviation 0
|
Adverse Events
Prebiotic
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Probiotic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Antibiotic
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Control
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 |
Prebiotic
n=8 participants at risk
Trametes versicolor extract: 1,200 mg, 3 times daily on an empty stomach for 14 days
|
Probiotic
n=8 participants at risk
Saccharomyces boulardii: 250 mg, 3 times daily on an empty stomach for 14 days
|
Antibiotic
n=8 participants at risk
Amoxicillin: 250 mg 3 times daily at least 1 hour before meals for 7 days
|
Control
n=8 participants at risk
Control group, no intervention given.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Soft stool
|
0.00%
0/8
|
0.00%
0/8
|
25.0%
2/8
|
0.00%
0/8
|
|
Gastrointestinal disorders
gas
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Gastrointestinal disorders
constipation
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place