A Controlled Trial to Evaluate the Effects of GanedenBC30 on the Immune System
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|