Phase 2 Reduction of Dietary Mycotoxin Exposure by ACCS100"

NCT01677195 | Completed Phase 2 Results DMC

• 1 other identifier: TxESI 12-001
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dietary Carcinogenesis

Keywords

Mycotoxins; Aflatoxin; Fumonisin; Aflatoxicosis; Dietary; Cancer

Outcome Measures

Primary Outcomes (1)

• AFB1-lysine Adduct (pg/mg) Overtime

  After randomization, participants provided serum samples at baseline, weeks 4, 12, and 16. Week 16 represents one month off treatment.

  3 months on intervention (weeks 0-12); 1 month off intervention (week 16)

Study Arms (3)

ACCS100 High Dose

ACTIVE COMPARATOR

Participants will receive a total daily dose of 3 grams of ACCS100; 1 gram three times a day with meals.

Drug: ACCS100

ACCS100 Low Dose

ACTIVE COMPARATOR

Participants will receive a total daily dose of 1.5 grams of ACCS100; 500 mgs three times a day with meals.

Drug: ACCS100

Placebo

PLACEBO COMPARATOR

Participants will receive placebo capsules shown not to absorb mycotoxins three times a day with meals.

Drug: Placebo

Interventions

ACCS100 DRUG

ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article.

Also known as: HSCAS, UPSN, NS

ACCS100 High Dose; ACCS100 Low Dose

Placebo DRUG

Placebo is calcium carbonate, USP. This calcium mineral does not absorb mycotoxins, specifically aflatoxin and fumonisin. This mineral has approximately the same physical appearance as active test article.

Also known as: Calcium Carbonate

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• Texas Enterosorbents Incorporated: lead
• Texas A&M University: collaborator
• University of Georgia: collaborator
• The University of Texas at San Antonio: collaborator

Study Sites (1)

University of Texas Health Science Center Cancer Therapy and Research Center

San Antonio, Texas, 78229, United States

Location

Related Publications (2)

• Robinson A, Johnson NM, Strey A, Taylor JF, Marroquin-Cardona A, Mitchell NJ, Afriyie-Gyawu E, Ankrah NA, Williams JH, Wang JS, Jolly PE, Nachman RJ, Phillips TD. Calcium montmorillonite clay reduces urinary biomarkers of fumonisin B(1) exposure in rats and humans. Food Addit Contam Part A Chem Anal Control Expo Risk Assess. 2012;29(5):809-18. doi: 10.1080/19440049.2011.651628. Epub 2012 Feb 10.

  PMID: 22324939 BACKGROUND

• Johnson NM, Qian G, Xu L, Tietze D, Marroquin-Cardona A, Robinson A, Rodriguez M, Kaufman L, Cunningham K, Wittmer J, Guerra F, Donnelly KC, Williams JH, Wang JS, Phillips TD. Aflatoxin and PAH exposure biomarkers in a U.S. population with a high incidence of hepatocellular carcinoma. Sci Total Environ. 2010 Nov 1;408(23):6027-31. doi: 10.1016/j.scitotenv.2010.09.005. Epub 2010 Sep 25.

  PMID: 20870273 BACKGROUND

MeSH Terms

Conditions

Aflatoxin Poisoning; Neoplasms

Interventions

ACCS100; sodium calcium aluminosilicate, hydrated; Calcium Carbonate

Condition Hierarchy (Ancestors)

Mycotoxicosis; Poisoning; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals

Limitations and Caveats

Unlike our clinical trials in Africa, where maximum compliance was achieved through the daily in-home monitoring, the current study relied on participant reports during monthly visits in which total compliance was difficult to assess.

Results Point of Contact

• Title: Dr. Bradley H. Pollock, PI
• Organization: University of Texas Health Science Center at San Antonio / University of California, Davis* current

pbollock@ucdavis.edu

(530) 752-7250

Study Officials

• Bradley H Pollock, MPH, Ph.D.

  University of Texas Health Science Center San Antonio Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2012
• First Posted: August 31, 2012
• Study Start: September 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: April 19, 2016
• Results First Posted: January 21, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)