At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 24 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Controlled Trial to Evaluate the Effects of GanedenBC30 on the Immune System
In Brief
A Phase 2 clinical trial evaluating GanedenBC30, GBI-30, PTA-6086 and Placebo for HIV Infection and Gastrointestinal Symptoms. Completed, enrolled 24 participants across 1 site.
Detailed Summary
Improvement in the rate of bacterial translocation may lead to a decrease in a chronic inflammatory response thereby decreasing CD4 destruction and HIV proliferation. By the addition of probiotics we hope to show a reduction in LPS leading to a decrease in chronic inflammation and therefore an improvement in immune markers.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infection, Gastrointestinal Symptoms
CountriesUnited States
CollaboratorsGaneden Biotech, Inc.
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2010
First PostedAug 2010
Primary CompletionJul 2012
TodayJul 2026
First PostedAug 19, 2010
Enrollment StartAug 1, 2010
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 15.9 years ago
Interventions
GanedenBC30, GBI-30, PTA-6086dietary
1 capsule per day containing 2 billion CFU of GanedenBC30, GBI-30, PTA-6086 for 90 days.
Placebodrug
1 capsule per day for 90 days.