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| ID | Type | Description | Link |
|---|---|---|---|
| GESIDA 9116 | Other Identifier | GESIDA Study group |
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Altered interplay between gut mucosa and dysbiotic bacteria during HIV infection seems to contribute to chronic immune dysfunction. Manipulation of the intestinal microbiota with nutritional interventions exert limited immunologic effects, but a deep understanding of how these interventions could ameliorate gut dysbiosis and influence health among HIV-infected individuals remain unexplored. In this Phase I clinical trial, 30 HIV-infected subjects on effective ART with evidence of persistent immune dysfunction, indicated by a CD4/CD8 ratio<1 will be included and randomized to either repeated low-dose oral fecal microbiota transplantation or placebo during 8 weeks. The primary outcome will be safety. Secondary outcomes will include changes in CD4+ T cell counts, CD8+ T cell counts, CD4/CD8 ratio, inflammatory markers, T cell activation and markers of enterocyte barrier function through week 48. Engraftment on host microbiota will be examined using Illumina sequencing of the V3-V4 16S RNA, and changes in bacterial metabolism and in the plasma metabolite fingerprint will be studied by combination of untargeted mass spectrometry and two different and complementary separation techniques in bacterial and plasma samples.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FMT | Experimental | Fecal microbiota capsules (provided by Openbiome). Dosage:
|
|
| Placebo | Placebo Comparator | Placebo capsules (provided by Openbiome). Dosage:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FMT | Biological | Capsules with fecal microbiota from healthy donors |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | From baseline through week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in CD4+ T cell counts | From baseline through week 48 | |
| Changes in CD8+ T cell counts |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Ramón y Cajal | Madrid | 28034 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33602945 | Derived | Serrano-Villar S, Talavera-Rodriguez A, Gosalbes MJ, Madrid N, Perez-Molina JA, Elliott RJ, Navia B, Lanza VF, Vallejo A, Osman M, Dronda F, Budree S, Zamora J, Gutierrez C, Manzano M, Vivancos MJ, Ron R, Martinez-Sanz J, Herrera S, Ansa U, Moya A, Moreno S. Fecal microbiota transplantation in HIV: A pilot placebo-controlled study. Nat Commun. 2021 Feb 18;12(1):1139. doi: 10.1038/s41467-021-21472-1. |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| Placebo |
| Other |
Placebo capsules |
|
| From baseline through week 48 |
| Changes in CD4/CD8 ratio |
| From baseline through week 48 |
| Changes in microbiota alpha diversity metrics | From baseline through week 48 |
| Changes in microbiota Unifrac distances | From baseline through week 48 |
| Changes in microbiota Canberra distances | From baseline through week 48 |
| Changes in plasma Interleukin-6 levels | From baseline through week 48 |
| Changes in plasma hs-CRP levels | From baseline through week 48 |
| Changes in plasma lipoteichoic acid levels | From baseline through week 48 |
| Changes in plasma LBP levels | From baseline through week 48 |
| Changes in plasma kynurenine/tryptophan ratio | From baseline through week 48 |
| Percentage of HLA-DR+/CD38+ T cells in blood | From baseline through week 48 |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |