SHIFT is a randomized, longitudinal, prospective, blinded, three-arm study to determine the safety and tolerability of Fecal Microbiota Transplant (FMT) in HIV-infected participants on stable antiretroviral therapy (ART).
This study is designed to test the safety and tolerability of Fecal Microbiota Transplant (FMT) in HIV infected individuals on stable antiretroviral therapy (ART). Additionally, the study will examine potential effects of FMT on HIV immune activation, which has been linked to HIV disease progression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Sieved fecal matter prepared in glycerol/saline solution
Placebo capsule manufactured to mimic Fecal Inoculum Capsules
Antibiotic pre-treatment
FMT-related adverse events
Safety of FMT in stably suppressed HIV infected recipients on ART
Time frame: 30 weeks
Immune and metabolic markers
Changes in immune and metabolic markers such as CD4 T cell activation and sCD14 levels.
Time frame: 30 weeks
Microbiome structure
Identify and characterize how FMT alters enteric microbiome structure.
Time frame: 30 weeks
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Placebo tablets manufactured to mimic antibiotics