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 CCRC: A Project of the Treatment of HIV Enteropathy With ImmunoLin® Supplements (NCT01313910), a na early/phase 1 study. The primary outcome is Number of Bowel Movements Per Day.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01313910 |
| Phase | EARLY/Phase 1 |
| Condition | HIV |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 8 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of California, Davis |
| Results posted | Yes |
2. Clinical Question
Population
Volunteers with HIV and persistent gastrointestinal symptoms. The registry record lists an enrollment of 8, but does not report further details about the participants or the population included in the primary analysis.
Intervention
ImmunoLin®, described as a dietary supplement, given as an 8-week treatment course.
Comparator
No separate comparator group is reported. The study is described as a single-group study, with allocation listed as not applicable.
Primary question
Whether bowel movements per day, recorded by participants in a diary, changed during the 8-week treatment period. The registry record does not report the primary endpoint values or the direction or size of any change.
The stated purpose was to examine whether ImmunoLin® would reduce bowel-movement frequency and gastrointestinal symptoms in volunteers with HIV and persistent gastrointestinal symptoms. The study also planned to examine gut bacteria and immune measures in gut tissue and blood. Those additional areas are described as study aims; the registry record does not report their results.
This is a within-group question, not a comparison of ImmunoLin® against a concurrent control. Even if measurements were taken before and after treatment, a change over time in one group would not by itself distinguish a treatment effect from other explanations for change. The record does not report enough endpoint data to describe whether a change was observed. The central statistical question is therefore what the study intended to measure, and what information would be needed to interpret a result—not whether the supplement produced a particular effect.
3. Trial Design
The registry identifies this as a completed early-phase 1 study sponsored by the University of California, Davis. It lists a single-group model, allocation as not applicable, and no masking. Enrollment was 8. The recorded start is 2011-03 and primary completion is 2012-08. The intervention was ImmunoLin®, categorized as a dietary supplement, with an 8-week treatment course.
Because the record describes one group and does not list a separate control arm, the design does not provide a concurrent like-for-like comparison. The study can be understood as a small pilot investigation of participants receiving the supplement, rather than a randomized comparison of treatment strategies. No information about a planned control condition, allocation procedure, or blinding procedure is reported in the registry record; allocation is listed as not applicable and masking as none.
The primary outcome was the number of bowel movements per day, described as self-reported bowel movements recorded in a diary. Its timeframe is 8 weeks (56 days). The registry also lists secondary outcomes concerning pro-inflammatory bacterial orders, gut permeability, systemic immune activation, and duodenal immune reconstitution. It reports 5 outcome measures and 4 analyses, but the record does not explain how those measures and analyses were organized or which analysis populations were used.
Completion status indicates that the study is recorded as completed; it does not establish that all enrolled participants completed treatment or contributed data to every outcome. Those participant-level details are not reported in the registry record. Nor are a protocol, statistical analysis plan, sample-size justification, interim analyses, or outcome analysis details reported. Consequently, design features beyond the fields should not be inferred.
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 | ImmunoLin® |
|---|---|
| STARTED | 8 |
| COMPLETED | 8 |
| NOT COMPLETED | 0 |
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.
| Characteristic | Unit | ImmunoLin® |
|---|---|---|
| Participants analysed | 8 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 8 |
| Age, Categorical: >=65 years | Participants | 0 |
| Age, Continuous | years | 44.5 (SD 4.5) |
| Sex: Female, Male: Female | Participants | 0 |
| Sex: Female, Male: Male | Participants | 8 |
| Region of Enrollment: United States | participants | 8 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Bowel Movements Per Day, measured over 8 weeks (56 days).
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | bowel movements/day |
| Endpoint classification | Time-to-Event Analysis |
The primary endpoint is the number of bowel movements per day, measured through participant self-report in a diary. The registry specifies a median as the summary measure and an inter-quartile range as the measure of dispersion. The stated timeframe is 8 weeks (56 days).
In general, bowel-movement frequency is a count-like daily measure. Summarizing it with a median describes the middle of the observed values and can be less influenced by unusually high or low values than a mean. The inter-quartile range describes the spread of the central portion of the observations. It conveys variability, but it is not itself a confidence interval and does not show the precision of an estimated treatment effect.
A diary can capture repeated self-reported observations over time, but its usefulness depends on how consistently entries are made and how the recorded observations are summarized. The registry description does not report the exact aggregation rule, whether the endpoint is a baseline-to-end comparison, or how incomplete diary entries were handled. Those details are not reported in the registry record.
Most importantly, the endpoint values are not reported in the registry record. There is no posted median, inter-quartile range, estimate of change, or confidence interval for this outcome. It is therefore not possible to describe the observed bowel-movement frequency or the precision of an estimated change from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the study's purpose and broad design, but it does not report numerical results for the primary endpoint. The planned measure was median bowel movements per day, summarized with an inter-quartile range, based on diary reports over an 8-week (56 days) timeframe. Without the observed values or a reported estimate of change, the direction, magnitude, and precision of a change cannot be evaluated.
No confidence interval or p-value for the primary endpoint is reported in the registry record. A confidence interval would ordinarily show a range of values compatible with the observed data and analysis, under the assumptions of that method. Without an estimate and its uncertainty, there is no basis to assess whether the data are compatible with a small or large change. A p-value, if reported, would address a different question and would not on its own describe the size or clinical importance of an effect. No such value is available in the record.
The single-group design further limits interpretation of change over time. In general, a before-and-after pattern in a group that all receives an intervention is not equivalent to a randomized treatment-versus-control contrast. Changes may reflect the intervention, but may also reflect factors such as natural fluctuation, changes in participants' circumstances, or the way observations are recorded. This is a general limitation of uncontrolled comparisons, not evidence that any such factor affected this study. The registry record does not report a control group or an adjustment strategy that would address these alternatives.
The record lists secondary outcomes related to gut bacteria, permeability, systemic immune activation, and duodenal immune reconstitution. Their inclusion indicates areas the study intended to examine, but does not establish that measurements were completed or that results were favorable, unfavorable, or statistically conclusive. Outcome-specific numerical results are not reported in the registry record.
The enrollment of 8 characterizes the scale of the registered study, but enrollment alone does not establish how many participants contributed to each endpoint. The registry does not report endpoint-specific analysis counts, missing observations, or participant flow. The safety fields list 8 at risk for the ImmunoLin® group and 0 affected for the recorded serious and other adverse-event categories; this should be read as a limited registry summary, not as evidence that all possible harms were assessed or absent. Overall, the posted information supports a description of the study's aims and design, but not an estimate of its primary outcome effect.
9. Statistical Methods Explained
What does the median describe?
The registry specifies the median for the primary endpoint. In general, the median is the central value after observations are ordered. It is often useful when a distribution is asymmetric or includes values far from most observations, because extreme values do not pull it in the same way they can pull a mean. This makes it a reasonable descriptive choice for a daily count that might vary across people or days. The median alone, however, does not show how much participants differ from one another, or how uncertain an estimated change is.
What does the inter-quartile range add?
The inter-quartile range describes the spread across the middle half of observations. Together, a median and inter-quartile range give a compact description of a distribution's center and variability. They do not automatically provide an inferential comparison. To judge the precision of a treatment-related estimate, readers would generally need an uncertainty measure, such as a confidence interval, with a clearly specified estimand and analysis. The registry record does not report an inter-quartile range value or an uncertainty interval for the primary endpoint.
Why does the single-group design matter?
In general, an intervention effect is most directly estimated by comparing outcomes between groups that differ in the intervention received, with the design and analysis addressing other sources of difference. This record describes a single group and no separate control. A within-group change, if it had been reported, would describe the observed pattern among participants over time, but would not alone identify what would have happened over the same period without the intervention. The registry does not report a randomized comparison, allocation procedure, or masking; allocation is listed as not applicable and masking as none.
This limitation is about the contrast the design can support. It does not mean that a single-group pilot has no descriptive value. Such a study can collect information on feasibility, observed measurements, and possible patterns that can motivate further research. But the ability to separate an intervention effect from other explanations is constrained when there is no concurrent comparison group. No causal effect estimate or comparative analysis is reported in the registry record.
How should repeated diary measurements be understood?
The outcome description refers to self-reported bowel movements in a diary over 8 weeks (56 days). Repeated records can contain more information about an individual's pattern than a single observation. However, the analysis must define how daily entries become a participant-level outcome and how missing days are treated. The registry record does not report the diary aggregation rule, adherence to diary recording, or procedures for incomplete records. These are general considerations for interpreting diary-based measures, not claims about what happened in this study.
It is also important to distinguish the number of recorded days from the number of independent participants. Repeated observations from one participant are related, so treating each daily entry as independent could understate uncertainty. A suitable method depends on the actual analysis plan and data structure. The analysis method and its assumptions are not reported in the registry record, so no conclusion can be drawn about how repeated measurements were handled.
What information would an uncertainty estimate provide?
In general, a confidence interval communicates the precision of an estimate by giving a range generated from the data and an inferential procedure. Its interpretation depends on the model, sampling assumptions, and the target quantity. A narrow interval can indicate greater precision than a wide interval, but neither width nor statistical significance alone determines whether an effect matters to participants. For a median-based endpoint, the interval method would also need to be appropriate for the quantity being estimated. No confidence interval, standard error, test statistic, or p-value for the primary endpoint is reported in the registry record.
Likewise, a p-value is not a measure of effect size and does not tell readers the probability that a treatment works. It quantifies how unusual the data would be under a specified null model and assumptions. Since no primary endpoint test result is reported, there is no p-value to interpret. It would be inappropriate to infer statistical significance from the study's completion status, its early-phase designation, or its enrollment.
Why do small studies require cautious reading?
In general, estimates from small studies tend to be imprecise, and observed values can be sensitive to individual observations. A small pilot may still be informative descriptively, but estimates should be accompanied by uncertainty and interpreted in light of the design. The registered enrollment is 8; the record does not report the number analyzed for the primary endpoint. Therefore, even the effective sample size for the primary analysis cannot be established from the record.
Planning calculations are not observed trial outcomes. In general, sample-size illustrations depend on assumptions about the effect to detect, variability, statistical model, allocation, and significance threshold. Here, the registry record does not report a sample-size justification or a trial-specific statistical plan. Any planning illustration should not be treated as an observed result or as observed power. The stated design is single-group, so a two-arm planning setup would not describe the registered design without additional assumptions. No trial-specific inferential method or planning rationale is reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The record lists 5 outcome measures and 4 analyses. It names the primary endpoint as number of bowel movements per day and lists secondary outcomes concerning pro-inflammatory bacterial orders, gut permeability, systemic immune activation, and duodenal immune reconstitution. It does not explain how the 5 outcome measures correspond to the 4 analyses, whether multiple time points or subgroups were examined, or which outcomes were included in each analysis.
When several outcomes or statistical tests are examined, the chance of at least one apparently notable result can increase. In general, a multiplicity strategy may define a primary hypothesis, adjust inference across selected tests, or distinguish confirmatory from exploratory analyses. The registry record does not report a multiplicity strategy, a hierarchy among secondary outcomes, or an analysis plan. Since numerical outcome results are also not reported, there is no basis to evaluate multiplicity-adjusted or unadjusted findings.
Missing-data procedures and analysis populations are not reported in the registry record. The primary outcome population field is blank, and there is no account of participants who completed treatment, posted diary data, or were included in each analysis. Enrollment of 8 should not be taken as confirmation that all 8 contributed complete primary endpoint information.
In general, missing observations can affect both the estimate and its uncertainty, particularly if the chance of missingness is related to symptoms or outcomes. Analyses may use different assumptions or approaches, such as complete-case analysis or methods that account for incomplete observations. The record does not state whether any such approach was used. No judgment about the likely direction or impact of missing data is possible from the information reported.
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 |
|---|---|---|---|
| ImmunoLin® | 0 | 8 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| ImmunoLin® | 0 of 8 |
For the ImmunoLin® group, the registry lists 8 participants at risk for serious adverse events and 0 affected. It also lists 8 at risk and 0 affected for the other adverse-event category. No top serious adverse-event terms are listed. These entries describe the safety fields recorded in the registry; they do not provide event narratives, timing, severity details, or an account of how events were collected and classified.
The deaths field is null, so deaths are not reported in the registry record. A null entry should not be converted into a claim of zero deaths. Similarly, 0 affected in the listed categories means that the registry reports no affected participants in those fields; it does not establish that every possible adverse experience was absent or that all participants were observed for the same duration.
In general, safety counts need context about definitions, follow-up, ascertainment, and the number of participants evaluated. This is particularly important when enrollment is small: a count of zero cannot rule out an event that was not observed in a limited study. The registry record does not report detailed safety methods or event-level information. The figures should therefore be read as the limited adverse-event summary recorded for this study, not as a complete characterization of safety.
12. What the Result Does, and Does Not, Mean
The registry identifies a completed pilot study of an 8-week ImmunoLin® course in volunteers with HIV and persistent gastrointestinal symptoms. Its primary outcome was diary-reported bowel movements per day, summarized using a median and inter-quartile range. The study also listed measures of gut bacteria, permeability, and immune activity as secondary outcomes. These details establish what the study set out to investigate.
They do not establish what the study found. The registry record does not report the primary endpoint values, a change estimate, a confidence interval, or a p-value. It also does not report numerical results for the listed secondary outcomes. No conclusion about the direction, magnitude, statistical precision, or clinical importance of an outcome can be drawn from the posted information.
The design also defines the scope of any possible interpretation. A single-group study without a separate control can describe observations among participants receiving the intervention, but a change over time alone would not establish that the intervention caused the change. This is a general interpretive limitation, not a claim about a result in this study. The registry does not report an analysis that compares outcomes with a control group.
Enrollment was 8, but the record does not say how many participants contributed data to each endpoint or whether all completed the treatment course. The adverse-event fields list 0 affected for the serious and other categories among 8 at risk, while the deaths field is not reported. These limited entries should not be read as a comprehensive assessment of all potential adverse experiences.
Accordingly, the strongest grounded interpretation is that the record documents the purpose, design, endpoint definition, and limited safety counts of a small pilot. It does not provide the outcome data needed to estimate an effect or its precision. The absence of results in the registry record is not evidence that there was no change; it leaves the change unknown.
13. Why This Trial Matters Statistically
This trial is statistically useful as an example of the distinction between a registered research question and an answer supported by reported data. The registry describes an intervention, a target population, and a primary measure, but does not report the primary outcome values. Without those values, there is no estimate to interpret and no uncertainty interval with which to assess precision.
It also illustrates why design matters before any result is considered. A single-group study and a randomized comparison answer different questions. In general, observations before and after treatment in one group can describe a time pattern, while a concurrent control can help separate that pattern from changes that might have occurred without the intervention. This record lists no control group, so a causal comparison is not part of the reported design.
The endpoint description provides another useful statistical distinction: a median and inter-quartile range summarize the center and spread of observations, but they do not by themselves quantify uncertainty in a treatment effect. A reader needs the actual data summary, a defined comparison or change, and an appropriate uncertainty measure to judge precision. Those outcome details are not reported in the registry record.
Finally, the enrollment of 8 and the brief safety counts reinforce the difference between the scale of a study and the strength of evidence it can provide. A pilot can be valuable for exploratory or descriptive purposes, but enrollment alone does not establish adequate precision, complete follow-up, or a definitive result. The registry does not report the sample-size rationale or analysis plan. This record therefore highlights the importance of transparent reporting of estimates, uncertainty, missing data, and analysis populations alongside the design description.
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 consequential limitation for interpreting this specific record is that the primary endpoint results are not reported in the registry record. Although the measure, summary statistic, dispersion measure, and timeframe are described, there are no posted values from which to assess bowel-movement frequency or change. There is also no reported confidence interval or test result.
The study is registered as single-group, with allocation not applicable and no masking. No separate comparator is reported. Consequently, even if a within-group change were available, the design would not by itself show what would have occurred over the same period without the intervention. This limitation is specific to the reported design, and it should not be confused with a finding that the intervention had no effect.
Enrollment was 8, but the record does not report the number of participants analyzed for the primary or secondary outcomes, completion of the 8-week course, or the extent of diary data. The primary outcome population field is blank. Missing-data methods and the handling of incomplete or inconsistent diary entries are not reported in the registry record.
The listed secondary outcomes cover several biological measures, but their results and analysis details are not reported. The record also does not describe a multiplicity strategy or identify how the 5 outcome measures relate to the 4 analyses. A sample-size justification, interim analyses, and a statistical analysis plan are not reported. These omissions prevent assessment of the intended inferential framework, precision targets, and any safeguards for interpreting multiple outcomes.
The safety summary is limited to registry counts: 0 affected for serious and other adverse-event categories among 8 at risk, with deaths not reported. The record does not supply event-level detail or further safety methods. Together, these limitations mean that the registered information supports a design description, but not a full assessment of efficacy, precision, completeness, or safety.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: CCRC: A Project of the Treatment of HIV Enteropathy With ImmunoLin® Supplements — NCT01313910.
- Registry record last updated 2017-06-15; status last verified 2017-05.
- Results first posted 2017-03-03.
- 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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18. Record Summary
This completed early-phase 1 study, sponsored by the University of California, Davis, enrolled 8 participants and evaluated an 8-week course of ImmunoLin® in volunteers with HIV and persistent gastrointestinal symptoms. It was registered as a single-group study, with allocation not applicable and no masking.
The primary endpoint was diary-reported number of bowel movements per day over 8 weeks (56 days), summarized by median and inter-quartile range. Secondary outcomes addressed pro-inflammatory bacterial orders, gut permeability, systemic immune activation, and duodenal immune reconstitution. The registry record does not report primary or secondary outcome results, analysis populations, or missing-data procedures.
The safety record lists 0 serious and 0 other adverse events among 8 at risk; deaths are not reported in the registry record. The available record therefore describes the study's aims and design but does not permit estimation of the primary outcome effect or its precision.