Trial Outcomes & Findings for Effect of Probiotic Supplementation on Endothelial Function (NCT NCT01952834)
NCT ID: NCT01952834
Last Updated: 2016-01-21
Results Overview
A measurement of endothelial function in humans that reports the percent change in brachial artery diameter to a flow stimulus in the arm induced by 5 minutes of occlusion of flow to the arm. It is measured as the percent change from baseline diameter.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
21 participants
Primary outcome timeframe
% Change before and after 6 weeks of daily Probiotic
Results posted on
2016-01-21
Participant Flow
Participant milestones
| Measure |
GoodBelly Probiotic and Vancomycin
Good Belly Probiotic 2.7 oz Daily x 6 weeks Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days
GoodBelly Probiotic: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days
Vancomycin: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
GoodBelly Probiotic and Vancomycin
Good Belly Probiotic 2.7 oz Daily x 6 weeks Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days
GoodBelly Probiotic: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days
Vancomycin: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Effect of Probiotic Supplementation on Endothelial Function
Baseline characteristics by cohort
| Measure |
GoodBelly Probiotic and Vancomycin
n=21 Participants
Good Belly Probiotic 2.7 oz Daily x 6 weeks Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days
GoodBelly Probiotic: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days
Vancomycin: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days
|
|---|---|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
|
History of Hypertension
Hypertensive
|
11 participants
n=5 Participants
|
|
History of Hypertension
Non-Hypertensive
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: % Change before and after 6 weeks of daily ProbioticA measurement of endothelial function in humans that reports the percent change in brachial artery diameter to a flow stimulus in the arm induced by 5 minutes of occlusion of flow to the arm. It is measured as the percent change from baseline diameter.
Outcome measures
| Measure |
GoodBelly Probiotic and Vancomycin
n=20 Participants
Good Belly Probiotic 2.7 oz Daily x 6 weeks Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days
GoodBelly Probiotic: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days
Vancomycin: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days
|
|---|---|
|
Brachial Artery Flow Mediated Dilation
|
1.2 percent change
Standard Deviation 1.6
|
PRIMARY outcome
Timeframe: Change before and after 10 days of Vancomycin, approximately 12 weeks from baselinePopulation: Subgroup analyzed who volunteered to have vancomycin
Flow Mediated Dilation is measured as the percent change in brachial artery diameter as measured by high resolution ultrasound based on arterial diameter prior to and following 5 minute flow occlusion to the forearm . We measured the percent change in brachial diameter before vancomycin was started and again 10 days after vancomycin
Outcome measures
| Measure |
GoodBelly Probiotic and Vancomycin
n=13 Participants
Good Belly Probiotic 2.7 oz Daily x 6 weeks Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days
GoodBelly Probiotic: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days
Vancomycin: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days
|
|---|---|
|
Brachial Artery Flow Mediated Dilation
|
-0.2 percent change
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Change before and after 6 weeks of daily ProbioticCirculating cytokine measured in the plasma
Outcome measures
| Measure |
GoodBelly Probiotic and Vancomycin
n=18 Participants
Good Belly Probiotic 2.7 oz Daily x 6 weeks Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days
GoodBelly Probiotic: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days
Vancomycin: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days
|
|---|---|
|
Interleukin 8
|
-3.5 pg/mL
Standard Error 1.3
|
SECONDARY outcome
Timeframe: Change before and after 6 weeks of probioticPopulation: Subjects with plasma samples available pre and post probiotic supplementation
This is a circulating plasma cytokine
Outcome measures
| Measure |
GoodBelly Probiotic and Vancomycin
n=17 Participants
Good Belly Probiotic 2.7 oz Daily x 6 weeks Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days
GoodBelly Probiotic: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days
Vancomycin: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days
|
|---|---|
|
Interleukin-12
|
-10.4 pg/mL
Standard Error 3.9
|
Adverse Events
GoodBelly Probiotic and Vancomycin
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GoodBelly Probiotic and Vancomycin
n=21 participants at risk
Good Belly Probiotic 2.7 oz Daily x 6 weeks Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days
GoodBelly Probiotic: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days
Vancomycin: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days
|
|---|---|
|
Nervous system disorders
Stroke
|
4.8%
1/21 • Number of events 1 • Data on adverse events were collected over the 2 years of the open trial
The categorization scheme A) Severity: 1) Mild 2) Moderate 3) Severe B) Expectedness 1) Expected- those consistent with the protocol in nature, severity, or frequency or 2) Unexpected C) Attribution 1) Unrelated to Protocol 2) Possibly Related to the Protocol 3) Probably Related to the Protocol 4) Definitely Related to the Protocol
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place