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| ID | Type | Description | Link |
|---|---|---|---|
| 201118675 | Other Identifier | UC Davis |
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| Name | Class |
|---|---|
| Proliant Health & Biologicals | UNKNOWN |
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The purpose of the study is to see if ImmunoLin® will reduce the frequency of bowel movements and gastrointestinal (GI) symptoms in HIV volunteers with persistent GI symptoms. The study will also examine the effect of ImmunoLin® on the bacteria in the gut and the immune system in gut tissue as well as in the blood.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ImmunoLin® | Experimental | 8-week treatment course |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunolin® | Dietary Supplement | Immunolin® 500 mg capsules to be taken 5 capsules twice daily for eight weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Bowel Movements Per Day | self-reported bowel movement in diary | 8 weeks (56 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Pro-inflammatory Bacterial Orders | 16S rDNA sequencing for Bacteroidetes/Firmicutes ratio | 8 weeks |
| Measures of Gut Permeability | five-hour disaccharide absorption test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David M. Asmuth, MD | University of California, Davis Int Med: ID | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCD CTSC Clinical Research Center (CCRC) | Mather | California | 95655 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23660579 | Result | Asmuth DM, Ma ZM, Albanese A, Sandler NG, Devaraj S, Knight TH, Flynn NM, Yotter T, Garcia JC, Tsuchida E, Wu TT, Douek DC, Miller CJ. Oral serum-derived bovine immunoglobulin improves duodenal immune reconstitution and absorption function in patients with HIV enteropathy. AIDS. 2013 Sep 10;27(14):2207-17. doi: 10.1097/QAD.0b013e328362e54c. |
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Patients with diagnosis of HIV enteropathy are eligible for enrollment.
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| ID | Title | Description |
|---|---|---|
| FG000 | ImmunoLin® | 2.5 grams twice daily for eight weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ImmunoLin® | 8-week treatment course |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Bowel Movements Per Day | self-reported bowel movement in diary | Posted | Median | Inter-Quartile Range | bowel movements/day | 8 weeks (56 days) |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ImmunoLin® | 8-week treatment course |
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pilot open label study with eight subjects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Asmuth, MD | UCaliforniaDavis | 9167348695 | david.asmuth@ucdmc.ucdavis.edu |
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 8 weeks |
| Systemic Immune Activation | CD8+ T-cells with an activated phenotype (HLA-DR/CD38+ coexpression) | 8 weeks |
| Duodenal Immune Reconstitution | changes in duodenal lamina propria CD3+/CD4+ density by immunohistochemistry | 8 weeks |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Frequency of Pro-inflammatory Bacterial Orders | 16S rDNA sequencing for Bacteroidetes/Firmicutes ratio | Posted | Median | Inter-Quartile Range | ratio of Bacteroidetes/Firmicutes % | 8 weeks |
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| Secondary | Measures of Gut Permeability | five-hour disaccharide absorption test | Posted | Mean | Inter-Quartile Range | percentage absorption | 8 weeks |
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| Secondary | Systemic Immune Activation | CD8+ T-cells with an activated phenotype (HLA-DR/CD38+ coexpression) | Posted | Median | Inter-Quartile Range | % CD8/HLA-DR/CD38+ | 8 weeks |
|
|
|
| Secondary | Duodenal Immune Reconstitution | changes in duodenal lamina propria CD3+/CD4+ density by immunohistochemistry | Posted | Median | Inter-Quartile Range | CD3+/CD4+ per mm^2 lamina propria | 8 weeks |
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| 0 |
| 8 |
| 0 |
| 8 |
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