Effect of Probiotic Supplementation on the Immune System in Patients With Ulcerative Colitis in Amman, Jordan: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Effect of Probiotic Supplementation on the Immune System in Patients With Ulcerative Colitis in Amman, Jordan (NCT04223479), a randomized phase 2, phase 3 study. The primary outcome is The Level of Immunoglobulin (Ig) A.

2. Clinical Question

The trial record frames probiotics as an adjunct to medical therapy for ulcerative colitis and describes interest in inflammatory markers, immune response, and quality of life. The primary endpoint addresses one part of that broader question: the level of IgA at the stated follow-up time. It does not by itself capture all aspects of immune response, disease symptoms, or patients’ daily experience.

The posted primary comparison gives a mean difference of -61.79 mg/dL, with a confidence interval from -125.1 to 1.524 mg/dL and an unadjusted p-value of 0.056. The negative estimate means the observed mean was lower in the probiotic group than in the placebo group. The interval includes no difference, so the estimate is imprecise with respect to the direction of the underlying group difference. The result should be read as an uncertain estimate, not as a definitive finding about the effect of probiotics.

The registry record does not report the clinical importance threshold for IgA, or define what size of difference would matter to patients. Nor does it provide detailed criteria for selecting participants or the medical therapy being used alongside the study capsules. Those gaps limit how specifically the result can be interpreted.

3. Trial Design

The registry describes a randomized, quadruple-masked, parallel-group interventional study and lists its phase as phase 2 and phase 3. The sponsor is the University of Jordan. The condition under study is ulcerative colitis, and the title locates the study in Amman, Jordan. The registry status is completed; the recorded study start was 2020-01-15 and primary completion was 2022-03-01.

Random allocation is intended to make the treatment groups comparable, on average, with respect to both measured and unmeasured characteristics. Masking is intended to reduce the influence of knowledge about group assignment on care, participant experience, and outcome assessment. The registry labels masking quadruple but does not identify which four roles were masked. The brief summary describes the study as double-blind, so the record does not give a consistent level of detail about who was masked.

The brief summary describes a planned allocation of 20 patients to placebo and 20 to probiotics, with capsules taken three times a day and follow-up for six weeks. Elsewhere the registry records enrollment of 30. The posted results for the primary outcome list 12 participants in each group, as do the posted quality-of-life results. These figures describe different parts of the record: the summary’s intended recruitment, the registry enrollment field, and the outcome-specific posted data. The registry record does not explain the differences among them, so the reasons for the final outcome counts are not reported in the registry record.

Measurements described in the summary include demographic and anthropometric information, blood samples, and an IBD Quality of Life Questionnaire. The primary result available for interpretation is the six-week IgA measurement. The record lists a broader set of outcome measures, but does not provide additional completed analyses for most of them. It also does not report the detailed protocol, the original statistical analysis plan, or the trial’s own sample-size justification.

The parallel design compares groups receiving probiotic capsules or placebo over the same study period. The available group summaries describe means and standard deviations at follow-up. The registry does not state whether the reported comparison adjusted for baseline values or other covariates, or describe the analysis population used for the posted outcomes.

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

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 The Level of Immunoglobulin (Ig) A, measured over at the end of 6 weeks of follow-up.

The primary endpoint is the level of immunoglobulin A (IgA), measured in mg/dL at the end of six weeks of follow-up. The record says the measure was assessed using an immunoturbidimetric assay on a Cobas-C501 instrument. IgA is an immunoglobulin, a type of antibody involved in immune activity. In this trial, its level serves as a measurable laboratory indicator relevant to the study’s stated interest in immune response.

A continuous laboratory measure preserves information about the range of observed values rather than reducing each participant to a category. The group mean describes the average level in each arm, while the standard deviation describes the spread of individual values around that mean. Those summaries help characterize the endpoint, but do not describe every participant’s result or the full shape of the data distribution.

Comparing the group means at the specified follow-up gives a direct summary of the observed difference between the assigned groups. The posted mean difference is -61.79 mg/dL for probiotic minus placebo. That estimate describes the measured endpoint at follow-up; it does not establish why the groups differed or whether any difference is important to patients.

The registry record does not report a clinically meaningful threshold for IgA, a reference range relevant to this study population, or a validated interpretation linking a particular change in IgA to symptoms or clinical outcomes. Therefore, the endpoint can be interpreted as a laboratory measure of immune response, but its clinical implications cannot be established from the posted result alone.

7. Results Posted in the Registry

• Probiotic Group: mean 208.63 versus 270.42 on control; difference -61.79 (95% CI -125.10 to 1.52), standardized effect d = -0.78; z-test p = 0.056.

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.

Quality of Life of Patients

• 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:
  • Probiotic Group: mean 6.54 versus 4.96 on control; difference 1.58 (95% CI 0.84 to 2.32), standardized effect d = 1.72; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for Probiotic Group than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The registry record lists quality of life as a secondary outcome and posts a comparison at the same six-week follow-up as the primary IgA result. The numerical direction of the secondary comparison differs from that of the primary result: the quality-of-life mean difference is positive, while the IgA mean difference is negative. These measures capture different domains, so different directions are not inherently contradictory. A laboratory immune marker and a questionnaire score need not move together.

The presence of a posted secondary result provides additional information about the study’s broader aims, but it does not strengthen the primary estimate in a simple, automatic way. The record does not define a relationship between the quality-of-life measure and IgA, report a combined outcome, or state that one endpoint was intended to explain the other. The secondary finding therefore should be considered alongside, rather than as a replacement for, the primary result.

Unadjusted secondary results carry less weight when several outcomes are measured. The registry lists 22 outcome measures, but reports one secondary outcome and no reported analyses for the rest. Without a prespecified multiplicity procedure, an apparently notable result among multiple possible outcomes may be more vulnerable to chance findings. The record does not state which outcomes were selected for formal testing, how they were prioritized, or whether the posted secondary analysis was planned in advance.

Interpretation is also limited because the registry does not report the scoring direction or a clinically meaningful threshold for the quality-of-life measure. A higher numerical score cannot be translated confidently into a particular degree of patient benefit without that context. The secondary outcome adds a signal worth noting, but its clinical meaning and robustness are not established by the available record.

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

• Quality of Life of Patients

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous: IgA is recorded as a numerical concentration in mg/dL. For a continuous outcome, a group mean summarizes the average observed value, while a standard deviation describes how dispersed participant values are around that mean. The posted means are 270.4 mg/dL for placebo and 208.6 mg/dL for probiotics; the corresponding standard deviations are 71.79 mg/dL and 85.84 mg/dL. A mean and standard deviation are compact summaries, not a complete description of the individual observations.

What does the mean difference represent?

The mean difference compares the two group averages. In the posted comparison, the order is probiotic group minus placebo group. The estimate of -61.79 mg/dL therefore indicates that the observed mean was lower in the probiotic group. The sign depends on the order used for subtraction; reversing the order would reverse the sign without changing the underlying group data. The estimate is a difference between group averages, not an estimate of the change experienced by every participant.

What does the confidence interval add?

A confidence interval communicates uncertainty around an estimated effect. In general, a 95% confidence interval is produced by a method that, under its assumptions, would cover the target effect in 95% of repeated samples. It is not a statement that there is a 95% probability that the particular interval contains the true effect. The posted interval for the primary mean difference is -125.1 to 1.524 mg/dL. Since zero lies inside it, the data do not rule out no difference at the corresponding conventional two-sided level. The interval also includes estimates with different magnitudes and directions, so it does not pin down the size of the effect precisely.

How should the p-value be read?

The unadjusted p-value of 0.056 measures how unusual a test statistic at least as incompatible with the no-difference hypothesis would be if that hypothesis and the analysis assumptions were correct. It is not the probability that the null hypothesis is true. It is also not a measure of clinical importance. The planning illustration lists a two-sided significance level of 0.05, but the registry record does not report whether this was the prespecified threshold for the trial’s own primary analysis. At a 0.05 threshold, 0.056 does not cross the conventional cutoff.

Why do the group sizes and spread matter?

Uncertainty in a mean difference depends in part on the number of observations and on how much individual values vary. The posted primary outcome includes 12 participants in each group. The standard deviations, 71.79 mg/dL and 85.84 mg/dL, indicate appreciable variation among the observed values. Larger variation or fewer observations generally makes an estimate less precise, all else equal. This is a general statistical principle, not a claim about a specific unreported feature of the trial analysis.

The record gives no individual-level data, distribution plots, or diagnostics. It is therefore not possible to assess whether the outcome values were approximately symmetric, whether extreme values influenced the means, or whether the assumptions of the analysis were adequate. The comparison is described through means and standard deviations, but the registry does not report the exact test or model used in the original analysis.

What does randomization contribute?

Random allocation is a design method intended to reduce systematic differences between groups at the point of assignment. It supports a causal interpretation when the randomization is maintained and when follow-up and analysis are handled appropriately. Randomization does not guarantee that groups will be balanced on every characteristic in a small study. The registry record does not provide a baseline comparison or explain whether the reported analysis adjusted for baseline IgA.

Masking can reduce the influence of treatment knowledge on participants, study staff, and outcome assessment. The record labels the trial quadruple-masked, while the brief summary calls it double-blind. It does not identify the masked roles or resolve the difference in wording. The laboratory endpoint is measured with an assay, but the record does not state whether laboratory personnel were masked to allocation.

What do unadjusted analyses and multiple outcomes imply?

An unadjusted comparison is one reported without an adjustment for other variables or for multiple testing. The primary p-value is explicitly described as unadjusted. The record lists 22 outcome measures and posts one secondary outcome, but does not report analyses for the other measures. When many endpoints or comparisons are examined, the chance of at least one apparently unusual result can increase. A multiplicity strategy may address this, but none is reported in the registry record. Consequently, the secondary evidence should be interpreted with more caution than a single prespecified primary comparison.

Missing-data handling and analysis populations are also important. The registry does not report how many randomized participants lacked outcome data, why any data might be missing, whether the analysis was intention-to-treat, or how missing values were handled. Those details are needed to judge whether the posted comparison preserves the advantages of randomization and whether attrition could affect the estimate. No assumptions about those procedures can be made from the outcome summaries alone.

11. Confidence Intervals and Precision

The primary mean difference is -61.79 mg/dL, with a confidence interval from -125.1 to 1.524 mg/dL. The interval describes uncertainty around the estimated difference: values near its lower end represent a substantially lower mean in the probiotic group, while values near the upper end allow a small positive difference. Zero is included, so the posted interval does not exclude no difference.

The interval is broad in relation to the point estimate. This means the data do not determine the magnitude of the underlying difference precisely. The point estimate alone would give an incomplete picture: it identifies the direction and size of the observed contrast, while the interval shows that a range of materially different estimates remains compatible with the data under the analysis method.

Precision is affected by the number of observations and the variability of the measurements. The primary outcome summaries list 12 participants per group, and the standard deviations are 71.79 mg/dL in the placebo group and 85.84 mg/dL in the probiotic group. The record does not provide individual observations, so the influence of unusual values cannot be assessed. It also does not report whether baseline adjustment or another model was used to produce the posted interval.

The interval is not a range in which every participant’s IgA value falls, nor does it describe variation in an individual’s response. It concerns the group mean difference. Its interpretation also depends on the assumptions of the method used to calculate it; the registry record does not give enough detail to assess those assumptions fully.

Because the interval includes zero, the data do not establish a difference at the conventional two-sided level associated with a 95% interval. That does not establish equivalence or prove that there is no effect. A conclusion of equivalence would require a prespecified margin defining differences small enough to count as equivalent, and the registry record does not report such a margin. The interval instead indicates that the estimate remains uncertain, both in direction and in size.

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 planning figures are participants per arm, not total event counts. They are planning illustrations based on the observed effect, using a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The trial’s own original sample-size assumptions and justification are not reported in the registry record.

For the primary outcome, planning for 100% of the observed effect corresponds to 26 participants per arm for 80% power and 35 participants per arm for 90% power. Planning for 75% of the observed effect corresponds to 46 participants per arm for 80% power and 62 participants per arm for 90% power. Planning for 50% of the observed effect corresponds to 103 participants per arm for 80% power and 138 participants per arm for 90% power.

Power is the probability, under a specified effect and statistical model, of detecting that effect at the chosen significance level. The 80% column describes a design intended to have an 80% chance of meeting the statistical criterion if the assumed effect is the true effect and the planning assumptions hold. The 90% column describes the corresponding design target with a higher chance of detection. These are design targets, not guarantees about any particular study.

The rows illustrate how the assumed effect changes the planning requirement. A smaller effect is harder to distinguish from random variation, so it requires more participants per arm to reach the same power target under the stated assumptions. The curve represents this general relationship across effect assumptions; its values should be understood within the same planning framework. These figures are planning illustrations, not observed power.

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 = -61.790; pooled standard deviation σ = 79.127.
2. n = 2 × (1.96 + 0.842)² × 79.127² / -61.790² = 25.7, rounded up to 26 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 <- -61.79                      # observed difference in means
sigma <- 79.1274595194361                     # 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(4223479)
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 = 26 (80% power), 35 (90% power)
 75% of observed effect: n per arm = 46 (80% power), 62 (90% power)
 50% of observed effect: n per arm = 103 (80% power), 138 (90% power)
power.t.test: 26.7 
Simulated power at n = 26 per arm: 0.793 (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. Multiplicity, Missing Data and Analysis Populations

The registry record lists 22 outcome measures, while it posts one secondary outcome and no reported analyses for the remaining measures. Examining several outcomes can increase the opportunity for chance findings. Statistical approaches such as family-wise error control, false-discovery control, or a prespecified hierarchy can address multiplicity, but the registry record does not report which, if any, approach was planned or used. The posted secondary result is therefore best treated as less conclusive than a single prespecified primary comparison.

The record identifies IgA as the primary outcome, which helps distinguish the principal question from other measured outcomes. However, it does not provide the original protocol or statistical analysis plan, nor does it say whether the primary outcome was selected before results were known. It also does not report whether the secondary endpoint was prespecified in the analysis plan or whether additional outcomes were measured but not posted. Without those details, the extent of selective outcome reporting cannot be assessed.

Missing data can affect both precision and validity. The outcome summaries list 12 participants in each group, but the registry does not state how many randomized participants had measurements available at follow-up, whether any participants discontinued, or why any outcomes were missing. The record also does not describe imputation, complete-case analysis, or sensitivity analyses. Therefore, it is not possible to determine whether missingness could have changed the estimated group difference.

The analysis population is not reported in the registry record. It is not stated whether the comparison included all randomized participants, only participants with observed measurements, or another defined group. The registry also does not describe protocol deviations or adherence to the assigned capsules. These omissions make it difficult to judge how closely the posted results reflect the randomized comparison.

The record does not describe interim analyses, stopping rules, or the trial’s original sample-size justification. These aspects should not be inferred from the planning illustration, which is based on the observed effect and is separate from the original trial design. Overall, multiplicity, missing-data procedures, analysis populations, and the detailed prespecification of outcomes remain unreported in the registry record.

15. 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.

The posted safety figures report zero serious adverse events affecting participants in the probiotic formula capsule group and zero in the placebo group. The record also reports zero other adverse events affecting participants in either group, and zero deaths in both groups. The listed at-risk counts for these summaries are 12 in each group.

These figures describe the adverse-event information posted for the study; they do not show that an event is impossible or that no safety concerns could occur in other settings. With the limited outcome-specific counts recorded, the ability to detect uncommon events is limited. The registry does not provide event descriptions, severity grading beyond the serious-versus-other categories, timing, relatedness assessments, or details of how adverse events were collected.

No serious adverse-event terms are listed. The record does not report additional narrative explaining the safety monitoring process or whether all participants completed the same safety follow-up. The zero counts should therefore be read as the posted registry findings for this study, not as a broad conclusion about the safety of probiotic supplementation.

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

The primary result estimates a lower mean IgA level in the probiotic group than in the placebo group at the end of six weeks. The estimate is -61.79 mg/dL, but its confidence interval extends from -125.1 to 1.524 mg/dL and includes no difference. The unadjusted p-value is 0.056. Together, these results indicate uncertainty about the true group difference rather than a precise or conclusive estimate.

The result does not establish that probiotics raised or lowered immune function overall. IgA is one laboratory measure, while immune response includes broader biological processes. The registry also describes inflammatory markers and other blood measures as study interests, but most analyses are not reported. A single endpoint cannot represent every aspect of immune activity or ulcerative colitis.

The result also does not establish whether any difference in IgA is meaningful to patients. The record does not give a clinically important threshold or connect IgA values to symptoms, disease activity, or longer-term outcomes. The six-week follow-up addresses a limited period, and the registry does not provide evidence about persistence beyond that time.

The secondary quality-of-life result is a different type of outcome and should not be used to erase uncertainty in the primary comparison. The registry does not report a scoring interpretation threshold or multiplicity plan that would establish the strength of this secondary evidence. Nor does it provide detailed information on baseline values, missing outcomes, analysis population, or adjustment procedures.

Because the study is randomized, the design can support a comparison between assigned groups when the randomization and follow-up are appropriately handled. However, the available registry summaries are not enough to verify all those conditions. The posted results should be understood as evidence from this study record, with uncertainty and reporting limitations, rather than as a definitive answer about treatment effects or a basis for individual medical decisions.

17. Why This Trial Matters Statistically

This trial illustrates why a point estimate and its uncertainty should be read together. The observed primary mean difference has a clear numerical direction, but the confidence interval includes zero and extends across a range of possible differences. Focusing only on the point estimate could overstate certainty; focusing only on whether a p-value crosses a cutoff could conceal the range of effects still compatible with the data.

The record also shows the importance of keeping design information, enrollment fields, and outcome-specific results distinct. The brief summary describes a planned recruitment of 40 patients, the registry enrollment field records 30, and the primary outcome summaries list 12 participants per group. These entries do not explain one another, and the reasons for the differences are not reported in the registry record. Clear reporting of participant flow and analysis populations would help readers understand how the randomized study led to the posted estimates.

Multiple outcomes create another statistical challenge. The study’s stated interests span immune measures, inflammatory markers, and quality of life, while the record posts limited analyses and does not describe a multiplicity strategy. Prespecifying the primary question and explaining how secondary outcomes will be interpreted helps distinguish confirmatory evidence from exploratory findings.

Finally, planning requirements based on an observed effect are sensitive to the size of that effect. The illustrations show that detecting a smaller effect requires more participants per arm under the stated assumptions. Such calculations can clarify the trade-off between precision, effect size, and study size, but they are not a substitute for the trial’s original design justification, which is not reported in the registry record.

18. 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 outcome-specific summaries list 12 participants in each group, while the registry enrollment field records 30 and the brief summary describes an intended recruitment of 40. The record does not provide participant flow or explain these differences. Without that information, it is difficult to understand the transition from planned recruitment to enrollment and to the numbers contributing to the posted outcome summaries.

The registry does not report detailed eligibility criteria, baseline characteristics, baseline IgA, or the medical therapy participants received alongside the capsules. These omissions limit assessment of the population represented and whether the groups were similar in relevant characteristics before follow-up. The record also does not state whether the comparison adjusted for baseline values.

Follow-up for the primary endpoint is reported at six weeks. The record does not provide longer-term results, so persistence of any measured difference cannot be assessed. It also does not report a clinical interpretation threshold for IgA or a patient-relevant outcome linked to a particular IgA level.

Although the trial is labeled quadruple-masked, the registry does not identify the masked roles, and the brief summary uses the term double-blind. The record does not reconcile these descriptions or state whether laboratory assessors were masked. The analysis method, missing-data handling, and analysis population are also not reported.

The registry lists 22 outcome measures but reports only one secondary outcome and no analyses for the remaining measures. It does not describe multiplicity adjustment or provide the original protocol and analysis plan. These reporting gaps, alongside the imprecision of the primary estimate, limit the strength and breadth of conclusions that can be drawn from the posted results.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Effect of Probiotic Supplementation on the Immune System in Patients With Ulcerative Colitis in Amman, Jordan — NCT04223479.
• Registry record last updated 2024-09-19; status last verified 2024-09.
• Results first posted 2024-09-19.
• 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.

22. Record Summary

The registry describes a completed randomized, quadruple-masked, parallel-group study of probiotic capsules versus placebo in patients with ulcerative colitis in Amman, Jordan. Its listed phase is phase 2 and phase 3, and the sponsor is the University of Jordan. The brief summary describes six weeks of follow-up and planned recruitment of 40 patients; the registry enrollment field records 30.

The primary outcome is IgA in mg/dL at the end of six weeks. The posted mean difference, probiotic minus placebo, is -61.79 mg/dL, with a confidence interval from -125.1 to 1.524 mg/dL and an unadjusted p-value of 0.056. The interval includes no difference, leaving the estimate uncertain. The record also posts a quality-of-life secondary outcome, but does not report most of the listed outcome analyses.

Participant flow, missing-data procedures, analysis populations, multiplicity handling, detailed masking roles, and the original sample-size justification are not reported in the registry record.