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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01184456
Other study ID # AHF-GAN01
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date August 2010
Est. completion date July 2012

Study information

Verified date January 2021
Source AIDS Healthcare Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
GanedenBC30, GBI-30, PTA-6086
1 capsule per day containing 2 billion CFU of GanedenBC30, GBI-30, PTA-6086 for 90 days.
Drug:
Placebo
1 capsule per day for 90 days.

Locations

Country Name City State
United States AHF Research Center Beverly Hills California

Sponsors (2)

Lead Sponsor Collaborator
AIDS Healthcare Foundation Ganeden Biotech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effects of Daily Consumption of GanedenBC30 on Immune Function and Gastro-intestinal Issues 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.
30, 60, and 90 days.
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