This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Phase 2 Reduction of Dietary Mycotoxin Exposure by ACCS100" (NCT01677195), a randomized phase 2 study. The primary outcome is AFB1-lysine Adduct (pg/mg) Overtime.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01677195 |
| Phase | Phase 2 |
| Condition | Dietary Carcinogenesis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 234 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Texas Enterosorbents Incorporated |
| Results posted | Yes |
2. Clinical Question
Population
Persons in Bexar County, Texas, are the population named in the official title. The registry record does not report eligibility criteria or further demographic details for the population enrolled.
Intervention
ACCS100, described as hydrated sodium calcium aluminosilicate, was tested at a high dose of 3 grams per day or a low dose of 1.5 grams per day. Both regimens were taken three times a day with meals.
Comparator
The comparator was placebo capsules, described in the registry as not absorbing mycotoxins. They were taken three times a day with meals.
Primary question
The primary question concerned the mean AFB1-lysine adduct level, measured in pg/mg albumin, over the intervention period and after intervention stopped. The registry lists serum collection at baseline and weeks 4, 12, and 16, but does not report numerical results or an analysis comparing the groups.
3. Trial Design
The registry describes a randomized, double-masked, parallel Phase 2 trial. Its listed enrollment is 234. The study status is completed; the recorded start is 2012-09 and primary completion is 2014-08. These are record details, not evidence about the outcome of the trial.
The arms were ACCS100 High Dose, ACCS100 Low Dose, and Placebo. The high-dose description specifies a total daily dose of 3 grams, taken as 1 gram three times a day with meals. The low-dose description specifies a total daily dose of 1.5 grams, taken as 500 mgs three times a day with meals. The placebo capsules were described as not absorbing mycotoxins and were taken three times a day with meals. Allocation is listed as randomized, masking as double, and the model as parallel. The registry does not explain the randomization sequence, concealment procedures, or who was masked.
The study concerned dietary carcinogenesis and the potential effects of aflatoxin and fumonisin exposure. Its stated primary purpose was to evaluate ACCS100 in relation to harmful effects of aflatoxin exposure and fumonisin, described in the registry as a cancer promoter. The record characterizes ACCS100 as investigational for reducing harmful effects of mycotoxin exposure in humans.
The primary outcome is titled “AFB1-lysine Adduct (pg/mg) Overtime.” It is specified as a mean with standard deviation, measured at baseline, weeks 4 and 12, and week 16. Weeks 0–12 are described as on intervention, while week 16 is one month off intervention. The registry record does not report a single primary contrast, numerical outcome results, or an analysis plan.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | ACCS100 High Dose | ACCS100 Low Dose | Placebo |
|---|---|---|---|
| STARTED | 71 | 83 | 80 |
| COMPLETED | 42 | 51 | 50 |
| NOT COMPLETED | 29 | 32 | 30 |
Reasons for not completing this period:
| Reason | ACCS100 High Dose | ACCS100 Low Dose | Placebo |
|---|---|---|---|
| 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 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: Participants had detectable levels of aflatoxin in serum sample and were otherwise healthy.
| Characteristic | Unit | ACCS100 High Dose | ACCS100 Low Dose | Placebo | Total |
|---|---|---|---|---|---|
| Participants analysed | 71 | 83 | 80 | 234 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 71 | 83 | 80 | 234 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 | 0 |
| Age, Continuous | years | 41.1 (SD 13.8) | 39.2 (SD 13.9) | 42.2 (SD 13.6) | 41.1 (SD 13.8) |
| Sex: Female, Male: Female | Participants | 53 | 63 | 64 | 180 |
| Sex: Female, Male: Male | Participants | 18 | 20 | 16 | 54 |
| Region of Enrollment: United States | participants | 71 | 83 | 80 | 234 |
6. Primary Endpoint
The registry lists the primary outcome as AFB1-lysine Adduct (pg/mg) Overtime, measured over 3 months on intervention (weeks 0-12); 1 month off intervention (week 16).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | pg/mg albumin |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the mean level of AFB1-lysine adduct, expressed in pg/mg albumin. The registry says participants provided serum samples after randomization at baseline, weeks 4 and 12, and week 16. Week 16 is described as one month off treatment; the first twelve weeks are the intervention period.
In general, a biomarker can be used to quantify a biological measure related to an exposure or process of interest. AFB1-lysine adduct is the measure named by the registry for this trial’s primary outcome, which was intended to address aflatoxin exposure. A measurement in pg/mg albumin expresses the adduct quantity relative to albumin. Tracking the mean across scheduled collections could describe how the measure changes over time and whether observed patterns differ across assigned groups. These are general reasons to measure a biomarker; the registry record does not report evidence about how well this endpoint reflects exposure or predicts health outcomes.
The outcome is continuous, and the registry specifies the mean and standard deviation as its summary format. However, no mean values, standard deviations, between-group estimates, confidence intervals, or tests are reported. The record also does not state how measurements from the several collection times were combined or identify one time point as the primary comparison. Thus the endpoint is described, but its observed values and estimated treatment contrasts are not available in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a planned primary outcome and the schedule for collecting serum samples, but it does not provide numerical results for that outcome. It also lists no analysis entries. Consequently, there is no reported estimate of the mean AFB1-lysine adduct level in any arm, no reported difference between an ACCS100 arm and placebo, and no reported uncertainty interval or significance test. The posted information does not establish the direction, size, or precision of any biomarker change.
The outcome title uses the term “Overtime,” and the description names collections at baseline, weeks 4 and 12, and week 16. That establishes a repeated-measure schedule, not the statistical comparison used to assess change. The record does not say whether the primary inference was based on a particular follow-up time, an average over time, a trend, or another summary. It does not report a model for repeated measurements or state how baseline values entered an analysis. The registry flags the primary outcome as having several categories or time points and not being reduced to one comparison.
The trial includes high-dose ACCS100, low-dose ACCS100, and placebo arms. A comparison of each active regimen with placebo would address separate contrasts, while a comparison between the active regimens would address a different question. The registry record does not report which contrasts were tested, whether any were prespecified, or how multiple comparisons were handled. Without estimates and their uncertainty, the listed enrollment and study design cannot substitute for results.
The record does report adverse-event counts. It lists zero participants affected by serious adverse events in each arm, alongside counts for other adverse events. Those counts should be read as descriptive registry entries, not as a complete account of harms or proof that no serious event occurred in the broader study experience. Definitions, collection procedures, follow-up completeness, and the meaning of missing death entries are not reported in the registry record.
Overall, the registry permits a description of the design, endpoint schedule, and recorded safety counts. It does not permit a quantitative judgment about the primary biomarker outcome. No conclusion about benefit, lack of benefit, or clinical effect follows from the absence of posted estimates; absence of a result is not itself a result.
9. Statistical Methods Explained
The design and outcome description allow several statistical concepts to be explained, but they do not supply an analysis result. The trial is described as randomized, double-masked, and parallel, with high-dose, low-dose, and placebo arms. Random allocation is generally used to balance prognostic factors in expectation, while masking is generally intended to reduce the influence of treatment knowledge on participant behavior, outcome assessment, or other study procedures. These are general purposes of those design features. The registry record does not describe how randomization or masking was implemented or maintained.
What does a continuous endpoint mean?
The primary endpoint is a continuous measurement, summarized in the registry as a mean with standard deviation. A mean describes the center of observed measurements. A standard deviation describes their spread around that mean; it is not the same as the uncertainty in the estimated mean. In general, the standard error and a confidence interval are used to express uncertainty about an estimate. A confidence interval gives a range of values compatible with the data and the statistical procedure, under its assumptions. The registry reports no means, standard deviations, standard errors, confidence intervals, or tests for AFB1-lysine adduct.
Because the endpoint was collected repeatedly, an analysis could account for the fact that measurements from the same participant are related. In general, repeated-measure models can estimate change over time while representing within-participant correlation. Alternative approaches can focus on a selected follow-up time or summarize a trajectory differently. Those choices can yield estimates with different interpretations. The record names the collection schedule but does not report which approach was used, how incomplete repeated measurements were handled, or which time-related contrast was primary.
Why does the comparison need to be specified?
A treatment effect is not a single generic quantity: it depends on the groups and outcome being compared. An ACCS100 high-dose versus placebo contrast is distinct from a low-dose versus placebo contrast. A contrast between the two ACCS100 regimens would address a separate question. For a repeated outcome, each contrast also needs a time definition, such as a comparison at a particular visit or a comparison of changes across visits. The registry record does not report an analysis that identifies these contrasts or gives their estimates.
General statistical interpretation also distinguishes the estimated effect from its precision. A point estimate alone describes the observed contrast in the analysis; a confidence interval describes uncertainty around that estimate. A p-value, if reported, addresses compatibility of data with a specified null model under assumptions, not the probability that a treatment is effective. None of these inferential quantities is reported for the primary outcome. It is therefore not possible to assess either the estimated magnitude or its precision from the registry entry.
What does the planning information mean?
The registry includes planning assumptions for a sample-size illustration: a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. It specifies that non-time-to-event illustrations are expressed as participants per arm. These are planning assumptions, not observed trial findings. The record does not report a numerical illustration, and the assumptions are not identified as the trial’s original design justification. The registry does not report the trial’s own sample-size justification, target effect, or statistical power calculation. A planning illustration based on an observed effect should not be described as observed power.
For general context, sample-size planning considers how much information a study might need to detect a specified effect under stated assumptions. The answer depends on the target effect, variability, significance level, allocation, and analysis method. When several outcomes or contrasts are considered, the plan may also address the risk of false-positive findings across comparisons. The registry record does not provide enough detail to reconstruct such planning or determine whether it matched the analyses eventually performed.
Why can variability matter?
Standard deviation describes variation among measurements. In general, greater variability can make an estimate less precise when other design features are held constant. Some continuous outcomes may also show more variability than a simple normal model captures; over-dispersion refers broadly to variability exceeding what a chosen model assumes. Appropriate modeling can matter in that situation. The registry specifies a mean and standard deviation but does not describe the distribution of measurements, assess model assumptions, or state whether any adjustment for unusual variability was used. No claim about over-dispersion in this trial can be made from the record.
The record’s summary therefore supports explanation of the endpoint type, repeated collection schedule, and stated planning assumptions, but not reconstruction of the primary analysis. Model choice, covariate adjustment, handling of repeated measures, and inferential results are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
Multiplicity arises when an analysis considers more than one outcome, treatment contrast, time point, or other hypothesis. In general, testing several hypotheses can increase the chance of at least one false-positive finding if each is interpreted without regard to the others. Statistical plans may identify a primary contrast, use a hierarchy, or apply an adjustment; the appropriate approach depends on the questions and design. The registry record does not report a multiplicity strategy.
The primary outcome description includes serum measurements at baseline, weeks 4 and 12, and week 16, and the trial has high-dose, low-dose, and placebo arms. The record flags that the primary outcome has several time points and is not reduced to one comparison. It does not specify which time point or combination of times defines the main inference, nor does it say which arm comparisons were intended to be confirmatory. There are no reported analysis entries to clarify this.
Missing-data methods are also not reported in the registry record. The record does not give the number of available serum measurements at each collection, describe reasons for missing measurements, or state whether an analysis used all available observations or a restricted set. It does not describe imputation, sensitivity analyses, or assumptions about missingness. These omissions prevent assessment of how incomplete follow-up may have affected estimates.
The analysis population is not reported in the registry record. It is not stated whether the primary analysis included all randomized participants, participants who followed the assigned regimen, or another defined group. The posted enrollment is not enough to determine the population contributing measurements to an outcome analysis. Without an analysis population and missing-data account, the extent to which the reported endpoint would represent the randomized groups cannot be evaluated.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| ACCS100 High Dose | 0 | 71 | 0.0% |
| ACCS100 Low Dose | 0 | 83 | 0.0% |
| Placebo | 0 | 80 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| ACCS100 High Dose | 36 of 71 |
| ACCS100 Low Dose | 47 of 83 |
| Placebo | 38 of 80 |
Most frequent non-serious adverse event terms
| Event term | Organ system | ACCS100 High Dose | ACCS100 Low Dose | Placebo |
|---|---|---|---|---|
| Abdominal Discomfort | Gastrointestinal disorders | 16 of 71 | 22 of 83 | 20 of 80 |
| Constipation | Gastrointestinal disorders | 10 of 71 | 13 of 83 | 7 of 80 |
| Indigestion, reflux, heartburn | Gastrointestinal disorders | 10 of 71 | 8 of 83 | 8 of 80 |
| nausea | Gastrointestinal disorders | 6 of 71 | 6 of 83 | 3 of 80 |
| Headache | General disorders | 4 of 71 | 6 of 83 | 4 of 80 |
| Vomiting | Gastrointestinal disorders | 3 of 71 | 4 of 83 | 0 of 80 |
The registry reports serious adverse-event counts separately from other adverse-event counts. For ACCS100 High Dose, 71 participants are listed as at risk and 0 as affected by serious adverse events; the count affected by other adverse events is 36. For ACCS100 Low Dose, the corresponding entries are 83 at risk, 0 affected by serious adverse events, and 47 affected by other adverse events. For Placebo, they are 80 at risk, 0 affected by serious adverse events, and 38 affected by other adverse events.
These are counts as recorded, not rates adjusted for duration or exposure. The registry does not define the adverse-event categories in this entry, describe ascertainment or follow-up, or explain whether participants could contribute more than one event. Deaths are not reported in the registry record. No serious adverse-event terms are listed. Zero affected participants in the registry entries should be read as the posted count, not as proof that serious events were impossible or that all harms were assessed and excluded.
12. What the Result Does, and Does Not, Mean
The record establishes that a Phase 2 randomized, double-masked, parallel trial compared two ACCS100 dose regimens with placebo in persons in Bexar County, Texas. It identifies the primary measure as mean AFB1-lysine adduct in pg/mg albumin and describes serum collection at baseline, weeks 4 and 12, and week 16. It also reports arm-level counts for serious and other adverse events.
Those design and measurement details do not establish what happened to the primary endpoint. Numerical biomarker results, treatment contrasts, and uncertainty intervals are not reported in the registry record. Therefore, neither the direction nor the magnitude of any difference can be stated. The absence of a numerical result cannot be interpreted as evidence of no difference, just as the trial’s stated purpose cannot be interpreted as evidence of a favorable effect.
In general, a change in a biomarker is not automatically equivalent to a change in a health outcome. Interpretation would depend on the actual estimates, their precision, the analysis plan, the completeness of measurements, and the relationship between the biomarker and outcomes relevant to health. The registry record does not report clinical outcome results or establish that a biomarker change predicts a health benefit.
The adverse-event counts are similarly limited. They describe the entries posted for the listed arms, but do not include the definitions, time-at-risk detail, or complete safety methods needed for a comprehensive comparison. The counts cannot independently establish comparative safety.
In short, the record supports a description of the trial’s question, design, endpoint schedule, and posted safety counts. It does not support a conclusion that ACCS100 changed the primary measure, that the doses differed, or that any observed change would translate into a health effect.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of the distinction between a detailed design record and an interpretable result. The registry identifies randomization, masking, a parallel design, three treatment arms, a continuous primary endpoint, and repeated serum collection. These details clarify what the study set out to compare and what it planned to measure. Yet the registry does not provide the outcome estimates or analysis needed to answer the central quantitative question.
The repeated-measure schedule is particularly relevant to statistical interpretation. Measurements at baseline, weeks 4 and 12, and week 16 could describe a trajectory during treatment and after treatment ended. But a schedule alone does not identify the primary estimand: the precise group contrast, time point, and outcome summary that an analysis is intended to estimate. Without that specification, readers cannot tell which result would answer the stated primary question.
The three arms also make explicit reporting of contrasts important. High-dose versus placebo and low-dose versus placebo address separate comparisons. Clear prespecification and reporting can help readers distinguish primary inference from exploratory comparisons and understand how multiplicity was considered. The registry record does not report those analysis details.
More broadly, the record illustrates why enrollment and design features cannot replace effect estimates and precision. A completed randomized study may still be difficult to interpret when results, missing-data handling, analysis populations, and model choices are absent from the public entry. Statistical transparency requires more than knowing what was measured: it requires enough information to understand how the measurements were analyzed and how uncertain the conclusions are.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The most important trial-specific limitation in the registry record is the absence of numerical primary-outcome results. Although the endpoint and serum collection schedule are described, the record gives no arm means, standard deviations, contrasts, confidence intervals, or tests. It also lists no analysis entries. The registry flags the primary outcome as having several time points and not being reduced to a single comparison, leaving the main inferential contrast unclear.
The record does not describe eligibility criteria, participant characteristics, baseline biomarker values, or the number of endpoint measurements available at each visit. It does not report the analysis population, missing-data methods, or reasons for missing samples. As a result, readers cannot assess representativeness, completeness of follow-up, or the potential influence of missing observations.
Further analysis details are absent: the randomization procedure, masking implementation, statistical model, covariate adjustment, and multiplicity handling are not reported in the registry record. The stated sample-size assumptions describe a planning illustration, not the trial’s own design justification, and no numerical illustration is reported.
Safety interpretation is also constrained. The registry provides affected counts and at-risk counts, but does not report event definitions, ascertainment methods, exposure duration, or deaths. The figures therefore cannot fully characterize the safety profile or support a robust comparative safety analysis. These are limitations of what the registry record reports; they do not establish what was or was not available in other study documents.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Phase 2 Reduction of Dietary Mycotoxin Exposure by ACCS100" — NCT01677195.
- Registry record last updated 2016-04-19; status last verified 2016-03.
- Results first posted 2016-01-21.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry describes NCT01677195, a completed Phase 2 randomized, double-masked, parallel trial of ACCS100 versus placebo in persons in Bexar County, Texas. Listed enrollment is 234. The recorded study start is 2012-09, and primary completion is 2014-08.
The arms were ACCS100 High Dose, ACCS100 Low Dose, and Placebo. The primary outcome was mean AFB1-lysine adduct in pg/mg albumin, with serum samples described at baseline, weeks 4 and 12, and week 16. The registry reports no numerical primary-outcome results or analysis entries. It does list serious and other adverse-event counts by arm, but does not provide the detail needed for a complete safety assessment.
The record supports a description of the trial design and intended biomarker assessment. It does not report estimates that permit a quantitative interpretation of the primary outcome.