| Primary | Change in sCD14 From Baseline to Week 25/26 | Baseline is defined as the average of the Entry and Week 2 values. Week 25/26 is defined as the average of the Week 25 and Week 26 values. Absolute change was calculated as the value at Week 25/26 minus the value at Baseline. | Analysis used the per-protocol population. Participants 1) without Baseline AND Week 25/26 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) or with HIV-1 virologic failure were excluded. | Posted | | Mean | 95% Confidence Interval | ug/L | | Weeks 0, 2, 25, and 26 | | | | ID | Title | Description |
|---|
| OG000 | Visbiome Extra Strength | Visibiome: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. | | OG001 | Placebo for Visbiome Extra Strength | Placebo: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00041(-94.1 to 176.2)
- OG00192.3(-48.5 to 233.2)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | t-test, 2 sided | 2-sample t-test with equal variance. | 0.60 | | Mean Difference (Net) | -51.3 | | | 2-Sided | 95 | -246 | 143.9 | | | Mean difference is Visbiome ES mean minus placebo mean. | | Superiority | | |
|
| Secondary | Change in IL-6 From Week 2 to Week 26 | IL-6 data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript. | These data were not assayed and the analysis was abandoned. | Posted | | | | | | Weeks 2 and 26 | | | | ID | Title | Description |
|---|
| OG000 | Visbiome Extra Strength | Visibiome: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. | | OG001 | Placebo for Visbiome Extra Strength | Placebo: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. |
| |
| Secondary | Change in IP-10 From Week 2 to Week 26 | All values were log10 transformed prior to calculating change and conducting analyses. Absolute change was calculated as the value at Week 26 minus the value at Week 2. Mean changes were exponentiated to be back on the untransformed scale and corresponds to a mean fold change. | Analysis used the per-protocol population. Participants 1) without Baseline AND Week 25/26 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) or with HIV-1 virologic failure were excluded. Additionally, participants without Week 2 and Week 26 IP-10 data were excluded. | Posted | | Mean | 95% Confidence Interval | Fold change | | Weeks 2 and 26 | | | | ID | Title | Description |
|---|
| OG000 | Visbiome Extra Strength | Visibiome: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. | | OG001 | Placebo for Visbiome Extra Strength | Placebo: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. |
| |
| Secondary | Change in sCD163 From Week 2 to Week 26 | sCD163 data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript. | These data were not assayed and the analysis was abandoned. | Posted | | | | | | Weeks 2 and 26 | | | | ID | Title | Description |
|---|
| OG000 | Visbiome Extra Strength | Visibiome: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. | | OG001 | Placebo for Visbiome Extra Strength | Placebo: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. |
| |
| Secondary | Change in sTNF-RI From Week 2 to Week 26 | sTNF-RI data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript. | These data were not assayed and the analysis was abandoned. | Posted | | | | | | Weeks 2 and 26 | | | | ID | Title | Description |
|---|
| OG000 | Visbiome Extra Strength | Visibiome: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. | | OG001 | Placebo for Visbiome Extra Strength | Placebo: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. |
| |
| Secondary | Change in Oxidized LDL From Week 2 to Week 26 | Oxidized LDL data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript. | These data were not assayed and the analysis was abandoned. | Posted | | | | | | Weeks 2 and 26 | | | | ID | Title | Description |
|---|
| OG000 | Visbiome Extra Strength | Visibiome: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. | | OG001 | Placebo for Visbiome Extra Strength | Placebo: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. |
| |
| Secondary | Change in Kynurenine to Tryptophan Ratio From Week 2 to Week 26 | Fold change was calculated as the value at Week 26 divided by the value at Week 2. | Analysis used the per-protocol population. Participants 1) without Baseline AND Week 25/26 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) or with HIV-1 virologic failure were excluded. | Posted | | Mean | 95% Confidence Interval | ratio | | Weeks 2 and 26 | | | | ID | Title | Description |
|---|
| OG000 | Visbiome Extra Strength | Visibiome: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. | | OG001 | Placebo for Visbiome Extra Strength | Placebo: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. |
| |
| Secondary | Change in D-dimer From Week 2 to Week 26 | All values were log10 transformed prior to calculating change and conducting analyses. Absolute change was calculated as the value at Week 26 minus the value at Week 2. Mean changes were exponentiated to be back on the untransformed scale and corresponds to a mean fold change. | Analysis used the per-protocol population. Participants 1) without Baseline AND Week 25/26 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) or with HIV-1 virologic failure were excluded. Additionally, participants without Week 2 and Week 26 D-dimer data were excluded. | Posted | | Mean | 95% Confidence Interval | Fold change | | Weeks 2 and 26 | | | | ID | Title | Description |
|---|
| OG000 | Visbiome Extra Strength | Visibiome: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. | | OG001 | Placebo for Visbiome Extra Strength | Placebo: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. |
| |
| Secondary | Change in LPS From Week 2 to Week 26 | LPS data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript. | These data were not assayed and the analysis was abandoned. | Posted | | | | | | Weeks 2 and 26 | | | | ID | Title | Description |
|---|
| OG000 | Visbiome Extra Strength | Visibiome: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. | | OG001 | Placebo for Visbiome Extra Strength | Placebo: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. |
| |
| Secondary | Change in LBP From Week 2 to Week 26 | LBP data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript. | These data were not assayed and the analysis was abandoned. | Posted | | | | | | Weeks 2 and 26 | | | | ID | Title | Description |
|---|
| OG000 | Visbiome Extra Strength | Visibiome: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. | | OG001 | Placebo for Visbiome Extra Strength | Placebo: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. |
| |
| Secondary | Change in CD4+ Cell Count From Week 2 to Week 26. | Absolute change was calculated as the value at Week 26 minus the value at Week 2. | Analysis used the per-protocol population. Participants 1) without Baseline AND Week 25/26 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) or with HIV-1 virologic failure were excluded. | Posted | | Mean | 95% Confidence Interval | cells/mm^3 | | Weeks 2 and 26 | | | | ID | Title | Description |
|---|
| OG000 | Visbiome Extra Strength | Visibiome: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. | | OG001 | Placebo for Visbiome Extra Strength | Placebo: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. |
| |
| Secondary | Change in CD4+/CD8+ Ratio From Week 2 to Week 26. | Fold change was calculated as the value at Week 26 divided by the value at Week 2. | Analysis used the per-protocol population. Participants 1) without Baseline AND Week 25/26 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) or with HIV-1 virologic failure were excluded. | Posted | | Mean | 95% Confidence Interval | ratio | | Weeks 2 and 26 | | | | ID | Title | Description |
|---|
| OG000 | Visbiome Extra Strength | Visibiome: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. | | OG001 | Placebo for Visbiome Extra Strength | Placebo: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. |
| |
| Secondary | Change in %CD14++CD16- From Week 2 to Week 26. | Absolute change was calculated as the value at Week 26 minus the value at Week 2. | Analysis used the per-protocol population. Participants 1) without Baseline AND Week 25/26 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) or with HIV-1 virologic failure were excluded. Additionally, participants without Week 2 and Week 26 %CD14++CD16- data were excluded. | Posted | | Mean | 95% Confidence Interval | Percent of %CD14++CD16- cells | | Weeks 2 and 26 | | | | ID | Title | Description |
|---|
| OG000 | Visbiome Extra Strength | Visibiome: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. | | OG001 | Placebo for Visbiome Extra Strength | Placebo: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. |
| |
| Secondary | Change in %CD14++CD16+ From Week 2 to Week 26 | Absolute change was calculated as the value at Week 26 minus the value at Week 2. | Analysis used the per-protocol population. Participants 1) without Baseline AND Week 25/26 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) or with HIV-1 virologic failure were excluded. Additionally, participants without Week 2 and Week 26 %CD14++CD16+ data were excluded. | Posted | | Mean | 95% Confidence Interval | Percent of %CD14++CD16+ cells | | Weeks 2 and 26 | | | | ID | Title | Description |
|---|
| OG000 | Visbiome Extra Strength | Visibiome: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. | | OG001 | Placebo for Visbiome Extra Strength | Placebo: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. |
| |
| Secondary | Change in %CD14lowCD16hi From Week 2 to Week 26 | %CD14lowCD16hi data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript. | These data were not assayed and the analysis was abandoned. | Posted | | | | | | Weeks 2 and 26 | | | | ID | Title | Description |
|---|
| OG000 | Visbiome Extra Strength | Visibiome: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. | | OG001 | Placebo for Visbiome Extra Strength | Placebo: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. |
| |
| Secondary | Change in %CD4+CD38+ From Week 2 to Week 26. | %CD4+CD38+ data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript. | These data were not assayed and the analysis was abandoned. | Posted | | | | | | Weeks 2 and 26 | | | | ID | Title | Description |
|---|
| OG000 | Visbiome Extra Strength | Visibiome: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. | | OG001 | Placebo for Visbiome Extra Strength | Placebo: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. |
| |
| Secondary | Change in %CD4+HLA-DR+ From Week 2 to Week 26. | %CD4+HLA-DR+ data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript. | These data were not assayed and the analysis was abandoned. | Posted | | | | | | Weeks 2 and 26 | | | | ID | Title | Description |
|---|
| OG000 | Visbiome Extra Strength | Visibiome: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. | | OG001 | Placebo for Visbiome Extra Strength | Placebo: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. |
| |
| Secondary | Change in %CD4+CD38+HLA-DR+ From Week 2 to Week 26. | Absolute change was calculated as the value at Week 26 minus the value at Week 2. | Analysis used the per-protocol population. Participants 1) without Baseline AND Week 25/26 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) or with HIV-1 virologic failure were excluded. Additionally, participants without Week 2 and Week 26 %CD4+CD38+HLA-DR+ data were excluded. | Posted | | Mean | 95% Confidence Interval | Percent of %CD4+CD38+HLA-DR+ cells | | Weeks 2 and 26 | | | | ID | Title | Description |
|---|
| OG000 | Visbiome Extra Strength | Visibiome: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. | | OG001 | Placebo for Visbiome Extra Strength | Placebo: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. |
| |
| Secondary | Change in %CD8+CD38+ From Week 2 to Week 26. | %CD8+CD38+ data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript. | These data were not assayed and the analysis was abandoned. | Posted | | | | | | Weeks 2 and 26 | | | | ID | Title | Description |
|---|
| OG000 | Visbiome Extra Strength | Visibiome: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. | | OG001 | Placebo for Visbiome Extra Strength | Placebo: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. |
| |
| Secondary | Change in %CD8+HLA-DR+ From Week 2 to Week 26. | %CD8+HLA-DR+ data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript. | These data were not assayed and the analysis was abandoned. | Posted | | | | | | Weeks 2 and 26 | | | | ID | Title | Description |
|---|
| OG000 | Visbiome Extra Strength | Visibiome: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. | | OG001 | Placebo for Visbiome Extra Strength | Placebo: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. |
| |
| Secondary | Change in %CD8+CD38+HLA-DR+ From Week 2 to Week 26. | Absolute change was calculated as the value at Week 26 minus the value at Week 2. | Analysis used the per-protocol population. Participants 1) without Baseline AND Week 25/26 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) or with HIV-1 virologic failure were excluded. Additionally, participants without Week 2 and Week 26 %CD8+CD38+HLA-DR+ data were excluded. | Posted | | Mean | 95% Confidence Interval | Percent of %CD8+CD38+HLA-DR+ cells | | Weeks 2 and 26 | | | | ID | Title | Description |
|---|
| OG000 | Visbiome Extra Strength | Visibiome: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. | | OG001 | Placebo for Visbiome Extra Strength | Placebo: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. |
| |
| Secondary | Change in %CD4+CD28-CD57+ From Week 2 to Week 26. | Absolute change was calculated as the value at Week 26 minus the value at Week 2. | Analysis used the per-protocol population. Participants 1) without Baseline AND Week 25/26 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) or with HIV-1 virologic failure were excluded. Additionally, participants without Week 2 and Week 26 %CD4+CD28-CD57+ data were excluded. | Posted | | Mean | 95% Confidence Interval | Percent of %CD4+CD28-CD57+ cells | | Weeks 2 and 26 | | | | ID | Title | Description |
|---|
| OG000 | Visbiome Extra Strength | Visibiome: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. | | OG001 | Placebo for Visbiome Extra Strength | Placebo: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. |
| |
| Secondary | Change in %CD8+CD28-CD57+ From Week 2 to Week 26. | Absolute change was calculated as the value at Week 26 minus the value at Week 2. | Analysis used the per-protocol population. Participants 1) without Baseline AND Week 25/26 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) or with HIV-1 virologic failure were excluded. Additionally, participants without Week 2 and Week 26 %CD8+CD28-CD57+ data were excluded. | Posted | | Mean | 95% Confidence Interval | Percent of %CD8+CD28-CD57+ cells | | Weeks 2 and 26 | | | | ID | Title | Description |
|---|
| OG000 | Visbiome Extra Strength | Visibiome: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. | | OG001 | Placebo for Visbiome Extra Strength | Placebo: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. |
| |
| Secondary | Change in Chao1 Richness Index From Week 2 to Week 26. | Absolute change was calculated as the value at Week 26 minus the value at Week 2. Chao1 is a diversity index that reflects how many different quantifiable types (species, individuals, items, etc…) there are in a dataset (see Chao reference). Chao1 diversity is a richness measure which quantifies how many different types there are in a given dataset. The Chao 1 index can range from 1 to infinity as it is constrained only by the number of types defined as measurable. The greater a value is, the more diverse it is but only in direct comparison to groups considering the same parameters. That is, diversity indices are relative to the community (cohort or ecosystem) studied in part due to the definition of the "types" that are considered. | Analysis used the per-protocol population. Participants 1) without Baseline AND Week 25/26 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) or with HIV-1 virologic failure were excluded. Additionally, participants without Week 2 and Week 26 Chao1 richness index data were excluded. | Posted | | Mean | 95% Confidence Interval | Estimator of species richness | | Weeks 2 and 26 | | | | ID | Title | Description |
|---|
| OG000 | Visbiome Extra Strength | Visibiome: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. | | OG001 | Placebo for Visbiome Extra Strength | Placebo: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. |
|
| Secondary | Change in Shannon Diversity Index From Week 2 to Week 26. | Absolute change was calculated as the value at Week 26 minus the value at Week 2. Shannon is a diversity index that reflects how many different quantifiable types (species, individuals, items, etc…) there are in a dataset (see Lemos and Magurran references). The Shannon index is an estimator of richness and evenness. It quantifies uncertainty (entropy) within a dataset. The Shannon Index ranges from 0-5. The greater a value is, the more diverse it is but only in direct comparison to groups considering the same parameters. That is, diversity indices are relative to the community (cohort or ecosystem) studied in part due to the definition of the "types" that are considered. | Analysis used the per-protocol population. Participants 1) without Baseline AND Week 25/26 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) or with HIV-1 virologic failure were excluded. Additionally, participants without Week 2 and Week 26 Shannon diversity index data were excluded. | Posted | | Mean | 95% Confidence Interval | Estimator of species richness & evenness | | Weeks 2 and 26 | | | | ID | Title | Description |
|---|
| OG000 | Visbiome Extra Strength | Visibiome: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. | | OG001 | Placebo for Visbiome Extra Strength | Placebo: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. |
|
| Secondary | Change in Chao1 Richness Index From Week 26 to Week 38. | Absolute change was calculated as the value at Week 38 minus the value at Week 26. Chao1 is a diversity index that reflects how many different quantifiable types (species, individuals, items, etc…) there are in a dataset (see Chao reference). Chao1 diversity is a richness measure which quantifies how many different types there are in a given dataset. The Chao 1 index can range from 1 to infinity as it is constrained only by the number of types defined as measurable. The greater a value is, the more diverse it is but only in direct comparison to groups considering the same parameters. That is, diversity indices are relative to the community (cohort or ecosystem) studied in part due to the definition of the "types" that are considered. | Analysis used the per-protocol population. Participants 1) without Baseline AND Week 25/26 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) or with HIV-1 virologic failure were excluded. Additionally, participants without Week 26 and Week 38 Chao1 richness index data were excluded. | Posted | | Mean | 95% Confidence Interval | Estimator of species richness | | Weeks 26 and 38 | | | | ID | Title | Description |
|---|
| OG000 | Visbiome Extra Strength | Visibiome: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. | | OG001 | Placebo for Visbiome Extra Strength | Placebo: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. |
|
| Secondary | Change in Shannon Diversity Index From Week 26 to Week 38. | Absolute change was calculated as the value at Week 38 minus the value at Week 26. Shannon is a diversity index that reflects how many different quantifiable types (species, individuals, items, etc…) there are in a dataset (see Lemos and Magurran references). The Shannon index is an estimator of richness and evenness. It quantifies uncertainty (entropy) within a dataset. The Shannon Index ranges from 0-5. The greater a value is, the more diverse it is but only in direct comparison to groups considering the same parameters. That is, diversity indices are relative to the community (cohort or ecosystem) studied in part due to the definition of the "types" that are considered. | Analysis used the per-protocol population. Participants 1) without Baseline AND Week 25/26 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) or with HIV-1 virologic failure were excluded. Additionally, participants without Week 26 and Week 38 Shannon diversity index data were excluded. | Posted | | Mean | 95% Confidence Interval | Estimator of species richness & evenness | | Weeks 26 and 38 | | | | ID | Title | Description |
|---|
| OG000 | Visbiome Extra Strength | Visibiome: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. | | OG001 | Placebo for Visbiome Extra Strength | Placebo: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. |
|
| Secondary | Change in I-FABP From Week 2 to Week 26. | Absolute change was calculated as the value at Week 26 minus the value at Week 2. | Analysis used the per-protocol population. Participants 1) without Baseline AND Week 25/26 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) or with HIV-1 virologic failure were excluded. Additionally, participants without Week 2 and Week 26 I-FABP data were excluded. | Posted | | Mean | 95% Confidence Interval | ng/mL | | Weeks 2 and 26 | | | | ID | Title | Description |
|---|
| OG000 | Visbiome Extra Strength | Visibiome: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. | | OG001 | Placebo for Visbiome Extra Strength | Placebo: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. |
| |
| Secondary | Safety | Summary of the highest adverse event grade (0-5) for each participant. Protocol definition of Adverse Events: 1) signs and symptoms Grade ≥3 and any that led to a change in treatment regardless of grade; 2) new diagnoses; 3) Grade ≥3 lab values and any that led to a change in treatment or were associated with a diagnosis were recorded, regardless of grade. DAIDS AE Grading Table, Version 2.0 was used. | All enrolled participants who initiated study treatment. | Posted | | Count of Participants | | Participants | | Treatment dispensation to Week 38 | | | | ID | Title | Description |
|---|
| OG000 | Visbiome Extra Strength | Visibiome: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. | | OG001 | Placebo for Visbiome Extra Strength | Placebo: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. |
| |
| Secondary | Tolerability | Tolerability was successfully completing the protocol-defined treatment period. | All enrolled participants who initiated study treatment. | Posted | | Count of Participants | | Participants | | Treatment dispensation to Week 38 | | | | ID | Title | Description |
|---|
| OG000 | Visbiome Extra Strength | Visibiome: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. | | OG001 | Placebo for Visbiome Extra Strength | Placebo: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily. |
| |