The Immune Directed Individualized Elimination Therapy (iDIET) Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for The Immune Directed Individualized Elimination Therapy (iDIET) Study (NCT05543512), a randomized na study. The primary outcome is Post-treatment Peak Eosinophil Count.

2. Clinical Question

3. Trial Design

The Immune Directed Individualized Elimination Therapy study, registered as NCT05543512, is a randomized, parallel-group pilot-feasibility trial in eosinophilic esophagitis. The registry lists an enrollment of 68 and an allocation described as randomized. It lists triple masking; the brief summary characterizes the study as double blind. The registry record does not clarify this difference in masking terminology.

Participants were assigned to individualized dietary elimination therapy or a sham diet, with both diets described as being followed for 8 weeks. The individualized diet was directed by an allergen-specific immune signature. A device intervention, an algorithm to diagnose food allergens, is also listed. The study is described as a pilot-feasibility study, so the reported findings should be read in that context rather than as definitive evidence about performance in a broader population.

The primary endpoint was post-treatment peak eosinophil count at 8 weeks. Three secondary outcomes are posted: Dysphagia Symptom Score, Endoscopic Severity, and Percentage of Histologic Responders. The primary outcome summaries contain 19 participants in the individualized diet group and 25 in the sham group. The safety summaries list 28 participants at risk in each group. The registry record does not explain how the populations represented by these outcome summaries relate to the overall enrollment or to one another.

The study status is completed. The registry record does not report the original sample-size justification, planned analysis populations, handling of missing outcomes, or a detailed statistical analysis plan. These omissions matter when interpreting a small pilot study: posted group summaries allow a direct descriptive comparison, but do not establish why particular sample sizes or analytic choices were made.

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.

Before assignment: Sixty-eight patients were assessed for eligibility and signed informed consent. Twelve did not meet inclusion criteria. Forty-seven participants received at least one exposure to a study intervention.

Overall Study

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.

6. Primary Endpoint

The registry lists the primary outcome as Post-treatment Peak Eosinophil Count, measured over 8 weeks.

The primary endpoint is post-treatment peak eosinophil count, measured in eosinophils per high-power field (eos/hpf) at 8 weeks. It describes the highest eosinophil count recorded in the esophageal tissue assessment at the stated follow-up. The registry identifies the endpoint as a continuous measure summarized by its mean and standard deviation.

In general, an endpoint is chosen to represent an outcome relevant to the study question in a form that can be compared between assigned groups. A tissue count provides a quantitative measure of eosinophilic inflammation in the esophagus. Reporting group means gives a summary of the observed values, while the standard deviation describes how spread out those values are within each group. Those summaries do not show the full distribution of individual results.

The posted means were 57.9 eos/hpf in the individualized diet group and 116.4 eos/hpf in the sham diet group. The posted comparison estimates the mean difference between groups, with the individualized diet group as the first group in the contrast. This is a group-level comparison at the specified follow-up, not a description of each participant's change from baseline. The registry record does not report additional detail about the measurement procedures or the endpoint's threshold for clinical interpretation.

7. Results Posted in the Registry

• Individualized Diet Elimination Therapy: mean 57.90 versus 116.40 on control; difference -58.50 (95% CI -98.97 to -18.03), standardized effect d = -0.82; z-test p = 0.005.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Dysphagia Symptom Score

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Individualized Diet Elimination Therapy: mean 21.00 versus 18.30 on control; difference 2.70 (95% CI -6.60 to 12.00), standardized effect d = 0.17; z-test p = 0.569.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Individualized Diet Elimination Therapy and the control. The interval gives the range of effects that remain compatible with the data.

Endoscopic Severity

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Individualized Diet Elimination Therapy: mean 3.80 versus 5.30 on control; difference -1.50 (95% CI -2.45 to -0.55), standardized effect d = -0.93; z-test p = 0.002.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Individualized Diet Elimination Therapy than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Percentage of Histologic Responders

• Endpoint type: Binary: the percentage of participants with the event (counts rebuilt from the posted percentages and group sizes).
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Individualized Diet Elimination Therapy: 26.3% (5/19) versus 12.0% (3/25) on control; risk difference 14.3 percentage points (95% CI -9.2 to 37.9), risk ratio 2.19 (0.60–8.06); unadjusted two-proportion z-test p = 0.223.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Individualized Diet Elimination Therapy and the control. The interval gives the range of effects that remain compatible with the data.

Across the secondary outcomes, the posted results do not form a uniform pattern of evidence. The sponsor's analyses report different p-values across symptom score, endoscopic severity, and histologic response, and the unadjusted recalculations likewise differ in their degree of uncertainty. This is relevant context for the primary result, but the secondary outcomes should not be treated as interchangeable measurements or as a single confirmatory test.

In general, secondary outcomes can add context by describing other dimensions of the study question. Their interpretation depends on how they were defined, collected, and analyzed. The registry lists Dysphagia Symptom Score, Endoscopic Severity, and Percentage of Histologic Responders at 8 weeks, but detailed scoring and responder criteria are not reported in the registry record. The available summaries therefore allow broad comparison between groups, but not a full appraisal of measurement choices or clinical thresholds.

Unadjusted secondary results carry less weight when several outcomes are tested because each additional test creates more opportunity for a result to appear notable by chance. Whether and how to adjust for multiplicity depends on the prespecified analysis plan and the role assigned to each outcome. Multiplicity adjustment is not reported in the registry record, and the planned hierarchy among outcomes is also not reported. The secondary findings are best considered supportive or exploratory rather than independent confirmation of the primary endpoint.

The registry lists four outcome measures and four analyses, but it does not provide enough information to determine whether all planned outcomes and analyses are represented or whether any were selected for reporting. This uncertainty reinforces the need to interpret the secondary pattern cautiously and to give greater emphasis to the registered primary endpoint and the sponsor's stated primary analysis.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Dysphagia Symptom Score
• Endoscopic Severity
• Percentage of Histologic Responders

9. Statistical Interpretation

10. Statistical Methods Explained

The primary endpoint is continuous, and the registry reports group means and standard deviations. A mean summarizes the central level of observations, while a standard deviation describes the spread of individual observations around that mean. The posted primary summaries are 57.9 with standard deviation 56.9 for the individualized diet group, and 116.4 with standard deviation 80.0 for the sham group. These statistics make it possible to describe the groups and to conduct an unadjusted comparison of their means.

What does the mean difference represent?

The recalculated mean difference is -58.5 eos/hpf, with the individualized diet group contrasted against the sham group. A negative estimate means the first group's mean is lower than the comparator group's mean under this ordering. The interval from -98.97 to -18.03 expresses uncertainty around that estimate using the posted summary statistics and an unadjusted comparison. It is not an interval for each participant's value, nor does it mean that every plausible individual response lies within those limits.

What does the t-test assess?

A two-sided t-test evaluates whether the observed difference in group means is compatible with a null hypothesis of no difference, allowing for departures in either direction. The sponsor reports a two-sided t-test for the primary comparison with p = 0.001. The unadjusted recalculation gives p = 0.005. These are p-values from distinct analyses. A p-value describes how unusual results at least as discrepant as the observed result would be under the test's null model and assumptions; it is not the probability that the null hypothesis is true, and it does not quantify the probability that the result will replicate.

In general, a t-test relies on assumptions about how observations are distributed and how the groups are sampled. The registry record identifies the sponsor's test but does not report diagnostic checks, transformations, or further details of its implementation. A recalculation from group summaries cannot reproduce analyses that rely on participant-level covariates or other adjustments.

How should the effect-size summary be read?

The recalculation also reports a standardized mean difference, d = -0.824. In general, standardizing a mean difference expresses it relative to the pooled standard deviation, which can assist comparisons across measures with different units. The standardized value is not a clinical threshold and does not replace interpretation of the original eos/hpf difference. The registry record does not report a threshold for judging the clinical importance of this endpoint.

How are the binary results compared?

The Percentage of Histologic Responders is a binary outcome reported as a percentage. The posted percentages are 26.0% for the individualized diet group and 12.0% for the sham group. The recalculation expresses the contrast as a risk difference of 0.143, with an interval from -0.092 to 0.379 and an unadjusted p-value of 0.223. The sponsor reports a chi-squared analysis with p = 0.22. In general, a risk difference describes the difference between the proportions meeting an outcome definition. The interval includes zero, so the posted unadjusted comparison does not distinguish the observed difference from no difference with high precision. The registry record does not include the responder definition in the listed outcome description.

A chi-squared test assesses whether categorical outcome proportions differ between groups under its assumptions. The small number of responders listed in the recalculation—5 in the individualized diet group and 3 in the sham group—also means the percentage summaries represent few events. The registry record does not report an alternative method for sparse binary data or adjustments for covariates.

Why can adjusted and unadjusted results differ?

An unadjusted comparison uses the posted group summaries without accounting for other variables. In general, an adjusted analysis can account for specified covariates and may produce a different estimate or p-value. The sponsor reports ANCOVA for Dysphagia Symptom Score and Endoscopic Severity, while the recalculations use the posted summary statistics for unadjusted mean differences. The registry record does not provide enough detail to reconstruct those adjusted models, including their covariates or estimates.

All recalculated comparisons are unadjusted. They are useful for a transparent reading of the posted summaries, but the sponsor's own analyses take precedence when describing the analysis reported by the study. The registry record does not state whether additional analyses were performed beyond those listed.

11. Confidence Intervals and Precision

Precision concerns how narrowly an estimate is located. For the primary endpoint, the unadjusted recalculated mean difference is -58.5 eos/hpf, and its 95% confidence interval runs from -98.97 to -18.03. The interval excludes zero, but it spans a range of possible differences rather than identifying a single exact value. Its width reflects uncertainty in the estimate under the assumptions of the unadjusted calculation.

In general, a confidence interval is a range generated by a method that, under repeated use and its assumptions, would cover the target quantity at the stated rate. It does not assign a probability to the fixed true difference being inside this particular interval. The interval also does not account for unreported sources of uncertainty, such as missing outcome data, model choices, or selective reporting.

Precision is limited by the number of participants contributing to the primary summaries: 19 in the individualized diet group and 25 in the sham group. The standard deviations, 56.9 and 80.0, indicate substantial spread relative to the group means. Thus the group average comparison should not be read as implying that individual results were similar to the average or that all participants had outcomes in the same direction.

The registry does not report a confidence interval for the sponsor's primary analysis. The recalculated interval is based on posted summary statistics and is unadjusted; it should not be presented as the sponsor's adjusted or primary-model interval. The original analysis plan, treatment of missing data, and analysis population are not reported in the registry record. Those omissions limit a full assessment of precision and possible bias.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size figures are planning illustrations based on the observed effect, not the original trial's design justification. For continuous outcomes, the entries are participants per arm, not a combined total. The stated assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, a normal approximation, and an effect to detect defined as the stated fraction of the observed effect. The registry record does not report the trial's own original sample-size assumptions or justification.

The 80% power column gives the estimated participants per arm for a future comparison to have an 80% chance of detecting the effect used in that row, if the planning assumptions and statistical model hold. The 90% power column uses a higher chance of detecting that same effect, and therefore generally requires more participants per arm. These are design-planning quantities, not probabilities that the observed result is correct.

Rows based on 100% of the observed effect use the full effect estimated in this trial. The 75% and 50% rows plan for smaller effects relative to that estimate. Smaller effects are harder to distinguish from random variation and require more participants per arm under the stated assumptions. For the binary endpoint, the same planning assumptions are stated, with figures also expressed as participants per arm; time-to-event outcomes, if present, would use total events, but none is posted among these outcomes.

These calculations are not observed power. They are hypothetical planning illustrations derived from the observed effect and should not be used as a retrospective score of whether the trial was adequately powered. The observed group summaries and uncertainty intervals remain the basis for interpreting the findings.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -58.500; pooled standard deviation σ = 71.026.
2. n = 2 × (1.96 + 0.842)² × 71.026² / -58.500² = 23.1, rounded up to 24 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -58.5                      # observed difference in means
sigma <- 71.0259811618256                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(5543512)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 24 (80% power), 31 (90% power)
 75% of observed effect: n per arm = 42 (80% power), 56 (90% power)
 50% of observed effect: n per arm = 93 (80% power), 124 (90% power)
power.t.test: 24.1 
Simulated power at n = 24 per arm: 0.800 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Analyses Reported by the Sponsor

The registry reports sponsor analyses for the primary and secondary outcomes. For the primary endpoint, the sponsor used a two-sided t-test and reported p = 0.001. The unadjusted recalculation from the posted group summaries gives a mean difference of -58.5 eos/hpf, a 95% confidence interval from -98.97 to -18.03, and p = 0.005. These are not identical analyses: the recalculation is a simple unadjusted comparison, while the sponsor's stated result is the reported trial analysis.

There is no flagged discrepancy between the posted primary result and the recalculation. Even so, the sponsor's own analysis takes precedence when stating the study's reported inferential result. The recalculation supplies a transparent estimate and interval from the published summary values; it does not replace the sponsor's analysis or establish its assumptions.

For the secondary outcomes, the sponsor reports ANCOVA for Dysphagia Symptom Score and Endoscopic Severity, and a chi-squared test for Percentage of Histologic Responders. The recalculations are unadjusted and use the posted summary data. The registry record does not report the covariates, model specifications, or detailed analysis populations used for the sponsor's analyses, so those results cannot be independently reconstructed from the record alone.

15. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when a study evaluates several outcomes or performs several statistical tests. In general, repeated testing can increase the chance of at least one apparently notable result even when the underlying effects are absent. Approaches to address this issue include prespecifying a primary outcome, defining a testing hierarchy, or adjusting significance thresholds. The registry identifies a primary endpoint and lists three secondary outcomes, but multiplicity adjustment and a testing hierarchy are not reported in the registry record.

The primary outcome should therefore be distinguished from the secondary results. The primary analysis is the central registered comparison, while the secondary findings provide additional context and should be interpreted with less confirmatory weight when no multiplicity strategy is reported. The registry record does not say whether the reported analyses represent all analyses planned or performed.

Missing data are another important uncertainty. The overall enrollment is 68, but the primary outcome summaries include 19 participants in the individualized diet group and 25 in the sham group. The safety summaries list 28 participants at risk in each group. The registry record does not explain these differences, identify the analysis population for each outcome, or report the extent and reasons for missing outcome data.

In general, the impact of missing outcomes depends on why the data are absent and how the analysis handles them. If availability is related to participants' outcomes or group assignment, a comparison of only observed values may not represent the full randomized groups. The registry record does not report imputation methods, sensitivity analyses, or a missing-data assumption, so the direction and size of any effect on the estimates cannot be determined from the posted information.

The record also does not report whether analyses followed intention-to-treat, per-protocol, or another population definition. It does not describe baseline adjustment for the primary endpoint or the treatment of protocol deviations. These omissions do not negate the posted results, but they limit the ability to assess bias, reproduce the analyses, and judge how well the estimates preserve the randomized comparison.

16. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent non-serious adverse event terms

The registry lists serious adverse events in 0 of 28 participants at risk in the individualized diet group and 0 of 28 participants at risk in the sham diet group. It reports no deaths in either group. Other adverse events are listed for 5 of 28 participants in the individualized diet group and 3 of 28 in the sham group.

These figures are counts of participants reported at risk and affected, not estimates of comparative safety with an uncertainty interval. In a pilot-feasibility study, a zero count of serious adverse events does not establish that such events cannot occur, and the other adverse-event counts do not by themselves establish a group difference. The registry record does not list serious adverse-event terms or provide details about event severity, timing, or attribution. The safety summaries also use a population that differs from the primary outcome summaries, and the record does not explain why.

17. What the Result Does, and Does Not, Mean

The posted primary data show a lower mean post-treatment peak eosinophil count in the individualized diet group than in the sham diet group at 8 weeks. The sponsor reports a two-sided t-test with p = 0.001, and an unadjusted recalculation from the posted summaries estimates a mean difference of -58.5 eos/hpf, with a 95% confidence interval from -98.97 to -18.03 and p = 0.005. These are statistical descriptions of this randomized comparison.

They do not establish that every participant in one group had a lower count than every participant in the other, nor do they specify the outcome an individual participant would have under either assignment. Group means and a confidence interval summarize uncertainty about an average contrast; they do not describe the full distribution of individual results. The registry record also does not report a threshold for interpreting the size of the eosinophil-count difference in clinical terms.

The trial is identified as a pilot-feasibility study, and the registry does not report the original design assumptions, missing-data methods, or detailed analysis populations. The primary outcome counts are lower than the overall enrollment, with no explanation in the record. These limitations leave uncertainty about the degree to which the posted summaries represent all randomized participants and how readily the estimate would generalize to other settings.

The secondary results add context but do not provide uniform confirmation, and multiplicity adjustment is not reported. The findings therefore should not be reduced to a single p-value or treated as a definitive conclusion about treatment effectiveness. They describe the observed results and analysis reported for this trial; they do not by themselves justify medical decisions or establish what would occur in a different population or study.

18. Why This Trial Matters Statistically

This trial is statistically informative because it places a randomized, sham-controlled comparison alongside a quantitative primary endpoint and several secondary measures. Random allocation is intended, in general, to support a fair comparison between groups by reducing systematic differences in treatment assignment. Sham control also frames the comparison against a diet condition rather than against no assigned diet. The registry lists triple masking, though its brief summary uses the term double blind.

The primary outcome is reported with group means and standard deviations, allowing an unadjusted difference and confidence interval to be calculated from the posted summaries. That makes it possible to discuss both the direction of the observed difference and its precision rather than relying on a p-value alone. The sponsor's reported test and the recalculation are both useful to distinguish, because they answer related questions through different analysis specifications.

The pilot-feasibility context is equally important. The posted outcome summaries include fewer participants than the stated enrollment, and the registry record does not explain the difference or describe the analysis populations. The record also does not report multiplicity handling or the original sample-size justification. These are not minor bookkeeping details: they affect how the estimates, uncertainty, and secondary findings can be evaluated.

For biostatisticians and clinical researchers, the study illustrates why a result should be read through its design, endpoint definition, analysis method, precision, and reporting completeness together. The posted data yield a clear descriptive contrast on the primary measure, while the record leaves important questions about missing information and generalizability unresolved.

19. 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.

Several limitations are specific to the information reported for this study. First, the registry lists enrollment of 68, but the primary outcome summaries include 19 participants in the individualized diet group and 25 in the sham group. The safety summaries list 28 participants at risk in each group. The registry record does not explain these different counts, state how many participants were randomized to each arm, or describe the populations included in each analysis.

Second, key analytic details are not reported in the registry record. These include the original sample-size justification, the primary analysis population, handling of missing outcomes, any baseline adjustment for the primary endpoint, and sensitivity analyses. The sponsor reports a two-sided t-test for the primary endpoint, but further implementation details are not reported. The registry also does not describe a multiplicity strategy for the secondary outcomes.

Third, the posted outcome descriptions do not provide the full measurement definitions. The registry lists the three secondary outcomes and their timeframes, but does not give detailed scoring procedures or the definition of a histologic responder. It also does not report a clinical-importance threshold for the primary endpoint. This limits interpretation of the scale and of the practical importance of group differences.

Finally, the record describes the study as a pilot-feasibility trial and provides a limited set of group summaries. The available data do not establish how representative the analyzed participants are of the enrolled population or how the findings apply outside the study. The record's different descriptions of masking—triple masking in the design fields and double blind in the brief summary—are not reconciled.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: The Immune Directed Individualized Elimination Therapy (iDIET) Study — NCT05543512.
• Registry record last updated 2026-08-28; status last verified 2026-08.
• Results first posted 2026-08-28.
• 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.

23. Record Summary

NCT05543512 is a completed randomized, parallel-group pilot-feasibility study of individualized immune signature-directed dietary elimination therapy versus a sham diet for eosinophilic esophagitis. Both assigned diets were described as lasting 8 weeks. The registry lists triple masking, while the brief summary describes the study as double blind.

The primary endpoint was post-treatment peak eosinophil count at 8 weeks. The posted means were 57.9 eos/hpf in the individualized diet group and 116.4 eos/hpf in the sham group. The sponsor reports a two-sided t-test with p = 0.001. The unadjusted recalculation estimates a mean difference of -58.5 eos/hpf, with a 95% confidence interval from -98.97 to -18.03.

Three secondary outcomes are posted. The registry record does not report the original sample-size justification, missing-data methods, analysis populations, or a multiplicity strategy. The primary outcome summaries contain fewer participants than the overall enrollment, with no explanation in the record.