Phase 2 Reduction of Dietary Mycotoxin Exposure by ACCS100" - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Prevention
Condition:	Dietary Carcinogenesis
Interventions:	Drug: ACCS100 Drug: Placebo

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Randomized, double blind, placebo controlled clinical trial of ACCS100 for the prevention of cancer associated with dietary Aflatoxin exposure. Recruitment occurred in Bexar and Medina Counties, Texas, USA from August 2012 through August 2014. The number of participants was 234 and 143 finished the study.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

Description

ACCS100 High Dose

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

ACCS100: 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.

ACCS100 Low Dose

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

ACCS100: 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.

Placebo

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

Placebo: 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.

Participant Flow: Overall Study

	ACCS100 High Dose	ACCS100 Low Dose	Placebo
STARTED	71	83	80
COMPLETED	42	51	50
NOT COMPLETED	29	32	30
Lost to Follow-up	14	22	22
Withdrawal by Subject	1	0	1
Adverse Event	6	4	1
Physician Decision	1	2	2
Pregnancy	0	1	0
Protocol Violation	7	3	4

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants had detectable levels of aflatoxin in serum sample and were otherwise healthy.

Reporting Groups

	Description
ACCS100 High Dose	Participants will receive a total daily dose of 3 grams of ACCS100; 1 gram three times a day with meals. ACCS100: 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.
ACCS100 Low Dose	Participants will receive a total daily dose of 1.5 grams of ACCS100; 500 mgs three times a day with meals. ACCS100: 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.
Placebo	Participants will receive placebo capsules shown not to absorb mycotoxins three times a day with meals. Placebo: 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.
Total	Total of all reporting groups

Baseline Measures

	ACCS100 High Dose	ACCS100 Low Dose	Placebo	Total
Number of Participants [units: participants]	71	83	80	234
Age [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	71	83	80	234
>=65 years	0	0	0	0
Age [units: years] Mean (Standard Deviation)	41.1 (13.8)	39.2 (13.9)	42.2 (13.6)	41.1 (13.8)
Gender [units: participants]
Female	53	63	64	180
Male	18	20	16	54
Region of Enrollment [units: participants]
United States	71	83	80	234

Outcome Measures

1. Primary:

AFB1-lysine Adduct (pg/mg) Overtime [ Time Frame: 3 months on intervention (weeks 0-12); 1 month off intervention (week 16) ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.

More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:

Name/Title: Dr. Bradley H. Pollock, PI
Organization: University of Texas Health Science Center at San Antonio / University of California, Davis* current
phone: (530) 752-7250
e-mail: pbollock@ucdavis.edu

Publications:

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 B₁ 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.

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.

Responsible Party:	Texas Enterosorbents Incorporated
ClinicalTrials.gov Identifier:	NCT01677195 History of Changes
Other Study ID Numbers:	TxESI 12-001
Study First Received:	August 29, 2012
Results First Received:	December 14, 2015
Last Updated:	March 20, 2016
Health Authority:	United States: Food and Drug Administration

Phase 2 Reduction of Dietary Mycotoxin Exposure by ACCS100" (RDMEACCS100)