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fecal microbiota-Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal-HIV infection
- Development stage
- Unknown
- Lead developer
- Fundación para la Investigación Biomédica del Hospital Universitario Ramón y Cajal
- Modality
- Synthetic Biology Platforms → Engineered Microbial Therapeutics → Microbiome Therapeutics, Fresh FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Yeast Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Defined Consortia → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Frozen FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Genetically Modified Bacteria → Engineered Microbial Therapeutics → Microbiome Therapeutics, Microbial Metabolites → Microbiome-Derived Products → Microbiome Therapeutics, Microbial Proteins → Microbiome-Derived Products → Microbiome Therapeutics, Complex Communities → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics
- Administration
- Oral
01
Overview
Fecal microbiota-Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal-HIV infection is an investigational fecal microbiota transplantation (FMT) therapy developed for treating persistent immune dysfunction in HIV-infected patients on stable antiretroviral therapy (ART). [7, 8] The therapy consists of oral capsules containing fecal microbiota from carefully selected donors known for high Faecalibacterium and butyrate profiles, which are associated with anti-inflammatory effects. [3, 6] The treatment's primary goal is to correct the gut microbiota dysbiosis linked to HIV infection, which is a contributor to chronic inflammation and immune system problems. [2, 3] It was evaluated in a Phase I/II randomized, double-blind, placebo-controlled study called the REFRESH trial (NCT03008941). [3, 8] In this trial, the therapy was administered in weekly low-doses for eight weeks and was found to be safe, increase gut microbiota diversity, and lead to improvements in intestinal damage markers and inflammatory proteins. [3, 7]
- Other names
- fecal microbiota transplantlow-dose oral fecal microbiota transplantation
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