Trial Outcomes & Findings for Phase 2 Reduction of Dietary Mycotoxin Exposure by ACCS100" (NCT NCT01677195)
NCT ID: NCT01677195
Last Updated: 2016-04-19
Results Overview
After randomization, participants provided serum samples at baseline, weeks 4, 12, and 16. Week 16 represents one month off treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
234 participants
Primary outcome timeframe
3 months on intervention (weeks 0-12); 1 month off intervention (week 16)
Results posted on
2016-04-19
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
71
|
83
|
80
|
|
Overall Study
COMPLETED
|
42
|
51
|
50
|
|
Overall Study
NOT COMPLETED
|
29
|
32
|
30
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
14
|
22
|
22
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
|
Overall Study
Adverse Event
|
6
|
4
|
1
|
|
Overall Study
Physician Decision
|
1
|
2
|
2
|
|
Overall Study
Pregnancy
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
7
|
3
|
4
|
Baseline Characteristics
Phase 2 Reduction of Dietary Mycotoxin Exposure by ACCS100"
Baseline characteristics by cohort
| Measure |
ACCS100 High Dose
n=71 Participants
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
n=83 Participants
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
n=80 Participants
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
n=234 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
71 Participants
n=99 Participants
|
83 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
234 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
41.1 years
STANDARD_DEVIATION 13.8 • n=99 Participants
|
39.2 years
STANDARD_DEVIATION 13.9 • n=107 Participants
|
42.2 years
STANDARD_DEVIATION 13.6 • n=206 Participants
|
41.1 years
STANDARD_DEVIATION 13.8 • n=7 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
180 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
54 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
71 participants
n=99 Participants
|
83 participants
n=107 Participants
|
80 participants
n=206 Participants
|
234 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 3 months on intervention (weeks 0-12); 1 month off intervention (week 16)After randomization, participants provided serum samples at baseline, weeks 4, 12, and 16. Week 16 represents one month off treatment.
Outcome measures
| Measure |
ACCS100 High Dose
n=71 Participants
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
n=83 Participants
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
n=80 Participants
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.
|
|---|---|---|---|
|
AFB1-lysine Adduct (pg/mg) Overtime
Baseline
|
3.77 pg/mg albumin
Standard Deviation 2.52
|
4.09 pg/mg albumin
Standard Deviation 2.25
|
4.26 pg/mg albumin
Standard Deviation 3.15
|
|
AFB1-lysine Adduct (pg/mg) Overtime
Week 4
|
3.00 pg/mg albumin
Standard Deviation 1.30
|
2.62 pg/mg albumin
Standard Deviation 1.08
|
3.06 pg/mg albumin
Standard Deviation 1.66
|
|
AFB1-lysine Adduct (pg/mg) Overtime
Week 12
|
2.87 pg/mg albumin
Standard Deviation 1.53
|
2.71 pg/mg albumin
Standard Deviation 1.35
|
3.22 pg/mg albumin
Standard Deviation 1.85
|
|
AFB1-lysine Adduct (pg/mg) Overtime
Week 16
|
2.74 pg/mg albumin
Standard Deviation 1.44
|
2.99 pg/mg albumin
Standard Deviation 1.26
|
3.03 pg/mg albumin
Standard Deviation 1.77
|
Adverse Events
ACCS100 High Dose
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
ACCS100 Low Dose
Serious events: 0 serious events
Other events: 47 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ACCS100 High Dose
n=71 participants at risk
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
n=83 participants at risk
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
n=80 participants at risk
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.
|
|---|---|---|---|
|
Gastrointestinal disorders
Indigestion, reflux, heartburn
|
14.1%
10/71 • Number of events 10 • The time fame for AE observations was baseline to follow-up period. 120 days total time with 90 days on treatment and 30 day follow-up.
|
9.6%
8/83 • Number of events 9 • The time fame for AE observations was baseline to follow-up period. 120 days total time with 90 days on treatment and 30 day follow-up.
|
10.0%
8/80 • Number of events 10 • The time fame for AE observations was baseline to follow-up period. 120 days total time with 90 days on treatment and 30 day follow-up.
|
|
Gastrointestinal disorders
nausea
|
8.5%
6/71 • Number of events 9 • The time fame for AE observations was baseline to follow-up period. 120 days total time with 90 days on treatment and 30 day follow-up.
|
7.2%
6/83 • Number of events 9 • The time fame for AE observations was baseline to follow-up period. 120 days total time with 90 days on treatment and 30 day follow-up.
|
3.8%
3/80 • Number of events 4 • The time fame for AE observations was baseline to follow-up period. 120 days total time with 90 days on treatment and 30 day follow-up.
|
|
Gastrointestinal disorders
Vomiting
|
4.2%
3/71 • Number of events 9 • The time fame for AE observations was baseline to follow-up period. 120 days total time with 90 days on treatment and 30 day follow-up.
|
4.8%
4/83 • Number of events 4 • The time fame for AE observations was baseline to follow-up period. 120 days total time with 90 days on treatment and 30 day follow-up.
|
0.00%
0/80 • The time fame for AE observations was baseline to follow-up period. 120 days total time with 90 days on treatment and 30 day follow-up.
|
|
Gastrointestinal disorders
Constipation
|
14.1%
10/71 • Number of events 10 • The time fame for AE observations was baseline to follow-up period. 120 days total time with 90 days on treatment and 30 day follow-up.
|
15.7%
13/83 • Number of events 21 • The time fame for AE observations was baseline to follow-up period. 120 days total time with 90 days on treatment and 30 day follow-up.
|
8.8%
7/80 • Number of events 9 • The time fame for AE observations was baseline to follow-up period. 120 days total time with 90 days on treatment and 30 day follow-up.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
22.5%
16/71 • Number of events 30 • The time fame for AE observations was baseline to follow-up period. 120 days total time with 90 days on treatment and 30 day follow-up.
|
26.5%
22/83 • Number of events 32 • The time fame for AE observations was baseline to follow-up period. 120 days total time with 90 days on treatment and 30 day follow-up.
|
25.0%
20/80 • Number of events 25 • The time fame for AE observations was baseline to follow-up period. 120 days total time with 90 days on treatment and 30 day follow-up.
|
|
General disorders
Headache
|
5.6%
4/71 • Number of events 4 • The time fame for AE observations was baseline to follow-up period. 120 days total time with 90 days on treatment and 30 day follow-up.
|
7.2%
6/83 • Number of events 8 • The time fame for AE observations was baseline to follow-up period. 120 days total time with 90 days on treatment and 30 day follow-up.
|
5.0%
4/80 • Number of events 4 • The time fame for AE observations was baseline to follow-up period. 120 days total time with 90 days on treatment and 30 day follow-up.
|
Additional Information
Dr. Bradley H. Pollock, PI
University of Texas Health Science Center at San Antonio / University of California, Davis* current
Phone: (530) 752-7250
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place