Trial Outcomes & Findings for A Controlled Trial to Evaluate the Effects of GanedenBC30 on the Immune System (NCT NCT01184456)
NCT ID: NCT01184456
Last Updated: 2021-01-13
Results Overview
The primary endpoint measurement of safety is measured based on the number of adverse events reported relative to the expected number adverse events prior to the start of the study based on a risk analysis. The primary endpoint measurement of immune function is measured based on biological markers including CRP, IL-8 and TNF-alpha between the two groups. The primary endpoint measurement of gastro-intestinal issues is measured based on the number of reported symptoms relative to the expected number of gastro-intestinal issues prior to the start of the study based on a risk analysis.
COMPLETED
PHASE2
24 participants
30, 60, and 90 days.
2021-01-13
Participant Flow
PI has left AIDS Healthcare Foundation, all efforts to locate the data have been exhausted and no data is available.
Participant milestones
| Measure |
GanedenBC30, GBI-30, PTA-6086
GanedenBC30, GBI-30, PTA-6086: 1 capsule per day containing 2 billion CFU of GanedenBC30, GBI-30, PTA-6086 for 90 days.
|
Placebo
Placebo: 1 capsule per day for 90 days.
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Controlled Trial to Evaluate the Effects of GanedenBC30 on the Immune System
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 30, 60, and 90 days.Population: PI has left AIDS Healthcare Foundation, all efforts to locate the data have been exhausted and no data is available.
The primary endpoint measurement of safety is measured based on the number of adverse events reported relative to the expected number adverse events prior to the start of the study based on a risk analysis. The primary endpoint measurement of immune function is measured based on biological markers including CRP, IL-8 and TNF-alpha between the two groups. The primary endpoint measurement of gastro-intestinal issues is measured based on the number of reported symptoms relative to the expected number of gastro-intestinal issues prior to the start of the study based on a risk analysis.
Outcome measures
Outcome data not reported
Adverse Events
GanedenBC30, GBI-30, PTA-6086
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Adam Sukhija-Cohen
AIDS Healthcare Foundation - Public Health Division
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place