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

This study has been completed.
Sponsor:
Collaborators:
Texas A&M University
University of Georgia
The University of Texas at San Antonio
Information provided by (Responsible Party):
Texas Enterosorbents Incorporated
ClinicalTrials.gov Identifier:
NCT01677195
First received: August 29, 2012
Last updated: March 20, 2016
Last verified: March 2016
Results First Received: December 14, 2015  
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
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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) ]


  Serious Adverse Events


  Other Adverse Events


  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:

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