A Controlled Trial to Evaluate the Effects of GanedenBC30 on the Immune System
|ClinicalTrials.gov Identifier: NCT01184456|
Recruitment Status : Unknown
Verified August 2010 by AIDS Healthcare Foundation.
Recruitment status was: Recruiting
First Posted : August 19, 2010
Last Update Posted : August 19, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infection Gastrointestinal Symptoms||Dietary Supplement: GanedenBC30, GBI-30, PTA-6086 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Controlled Trial to Evaluate the Effects of GanedenBC30 on the Immune System|
|Study Start Date :||August 2010|
|Estimated Primary Completion Date :||July 2011|
|Estimated Study Completion Date :||July 2011|
|Experimental: GanedenBC30, GBI-30, PTA-6086||
Dietary Supplement: GanedenBC30, GBI-30, PTA-6086
1 capsule per day containing 2 billion CFU of GanedenBC30, GBI-30, PTA-6086 for 90 days.
|Placebo Comparator: Placebo||
1 capsule per day for 90 days.
- Safety [ Time Frame: 30, 60, and 90 days. ]Assess adverse events.
- Improvement in CD4 cell counts. [ Time Frame: 90 days. ]Laboratory blood tests of CD4 lymphocytes.
- Improvement of gastrointestinal symptoms. [ Time Frame: 30, 60, and 90 days. ]Measure improvement in GSRS questionnaire scores.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01184456
|United States, California|
|AHF Research Center||Recruiting|
|Beverly Hills, California, United States, 90211|
|Contact: Robert Cordova, RN,BSN,CCRP 323-913-1033 Robert.Cordova@aidshealth.org|
|Principal Investigator: Homayoon Khanlou, MD|