Phase 2 Reduction of Dietary Mycotoxin Exposure by ACCS100"
Status:
Completed
Trial end date:
2014-08-01
Target enrollment:
Participant gender:
Summary
The primary purpose of the study is to evaluate the effectiveness of a naturally occurring
clay substance (ACCS100) in reducing harmful effects of aflatoxin exposure (a carcinogen) and
fumonisin (a cancer promoter). This clay substance contains of a variety of minerals
including calcium, sodium, potassium, and magnesium. UPSN and similar aluminosilicate
minerals have been regularly used as dietary supplements by humans and animals, and the
safety of this naturally occurring clay substance has been tested in clinical trials. The FDA
treats such minerals or nutritional supplements as a drug when tested for potential of
lessening the likelihood of disease (i.e., potential for mitigating disease).
This study involves the use of an investigational drug called Hydrated Sodium Calcium
Aluminosilicate (ACCS100). "Investigational" means that the "drug" has not yet been approved
by the U.S. Food & Drug Administration (FDA) for reducing harmful effects mycotoxin exposure
in humans.
Phase:
Phase 2
Details
Lead Sponsor:
Texas Enterosorbents Incorporated
Collaborators:
Texas A&M University The University of Texas at San Antonio University of Georgia