Phase 2 N=234 Randomized Double-blind Prevention

Phase 2 Reduction of Dietary Mycotoxin Exposure by ACCS100"

Dietary Carcinogenesis

Bottom Line

View on ClinicalTrials.gov: NCT01677195 ↗

Enrolled (actual)

234

Serious AEs

0.0%

Results posted

Jan 2016

Primary outcome: Primary: AFB1-lysine Adduct (pg/mg) Overtime — 3.77; 4.09; 4.26; 3.00 pg/mg albumin

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: ACCS100 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Texas Enterosorbents Incorporated
Primary completion: Aug 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY AFB1-lysine Adduct (pg/mg) Overtime	3.77; 4.09; 4.26; 3.00; 2.62; 3.06	—

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.

Eligibility Criteria

Inclusion Criteria

3.1 Participant Inclusion Criteria 3.1.1 Detectable blood AFB1-albumin adduct levels (limit of detection=0.01 pmol/mg albumin) 3.1.2 18 -85 years 3.1.3 Ability to take oral capsules 3.1.4 Negative urine pregnancy test for women of childbearing age 3.1.5 Must have the ability to understand and the willingness to provide a written informed consent to participate in the study

Exclusion Criteria

3.2 Participant Exclusion Criteria 3.2.1 History of known allergy to silicates 3.2.2 Pregnancy or lactation 3.2.3 History of significant neurological or psychiatric disorders that would impede giving consent, treatment, or follow up 3.2.4 Any serious systemic disorders incompatible with the study 3.2.5 History of chronic disease (ie heart disease, renal disease). A participant may have a diagnosis of and be managed for diabetes) Any recent diagnosis of cancer.

3.2.6 Participation in any other clinical study where the participant is actively taking an investigational medication within the last 30 days

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01677195). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.