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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Immunolin® 500 mg capsules to be taken 5 capsules twice daily for eight weeks
UCD CTSC Clinical Research Center (CCRC)
Mather, California, United States
Number of Bowel Movements Per Day
self-reported bowel movement in diary
Time frame: 8 weeks (56 days)
Frequency of Pro-inflammatory Bacterial Orders
16S rDNA sequencing for Bacteroidetes/Firmicutes ratio
Time frame: 8 weeks
Measures of Gut Permeability
five-hour disaccharide absorption test
Time frame: 8 weeks
Systemic Immune Activation
CD8+ T-cells with an activated phenotype (HLA-DR/CD38+ coexpression)
Time frame: 8 weeks
Duodenal Immune Reconstitution
changes in duodenal lamina propria CD3+/CD4+ density by immunohistochemistry
Time frame: 8 weeks
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