The purpose of this study is to determine whether oral fecal microbiota transplantation (FMT) is safe for people with human immunodeficiency virus (HIV) infection.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
All subjects will receive one dose per week for 6 weeks (6 total doses) of PRIM-DJ2727 oral capsules containing lyophilized microbiota product derived from 150 grams of healthy donor stool.
Thomas Street Health Center
Houston, Texas, United States
Number of participants with adverse events related to study drug
Time frame: 52 weeks
Cumulative of adverse events related to study drug
Time frame: 52 weeks
Severity of adverse events related to study drug
Severity of adverse events will be based on Division of AIDS (DAIDS) grading criteria.
Time frame: 52 weeks
Change in the intestinal microbiome diversity
Time frame: week 0, week 6
Change in the intestinal microbiome abundance of genera
Time frame: week 0, week 6
Change in systemic inflammation as assessed by interleukin 6 (IL-6) levels
Time frame: week 0, week 6
Change in microbial translocation as assessed by soluble cluster of differentiation (CD14) levels
Time frame: week 0, week 6
Change in gut barrier integrity as assessed by intestinal fatty acid binding protein (I-FABP)
Time frame: week 0, week 6
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.