MedTrace Logo

A Controlled Trial to Evaluate the Effects of GanedenBC30 on the Immune System

NCT01184456 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-01-13

Study results available
· View outcomes & findings →

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.

Conditions

  • HIV Infection
  • Gastrointestinal Symptoms

Interventions

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.

Sponsors & Collaborators

  • Ganeden Biotech, Inc.

    collaborator INDUSTRY

  • AIDS Healthcare Foundation

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01184456 on ClinicalTrials.gov