Rifaximin to Modify the Disease Course in Sickle Cell Disease
Status:
Unknown status
Trial end date:
2020-07-22
Target enrollment:
Participant gender:
Summary
In this single-arm, one-stage Phase II study, the investigators hypothesize that gut
decontamination with rifaximin will reduce the frequency of hospital admission due to painful
crisis in patients with SCD. The study will accrue 20 SCD patients who had at least two
hospital admissions in the previous 12 months. These patients will receive rifaximin 550 mg
twice a day for a total of 12 months. This following clinical parameters will be measured: 1.
Changes in the annual rate of hospital admissions due to painful crisis; 2. Changes in the
annual rate of days hospitalized; 3. Annual rates of uncomplicated crises; 4. Annual rate of
acute chest syndrome; 5. Changes in the quality of life; and 6). Toxicities. The following
laboratory parameters will be measured: 1. Changes in the number of circulating activated
neutrophils; 2. Changes in the intestinal microbiome diversity; 3. Changes in the urinary
3-indoxyl sulfate levels; 4. Changes in the serum biomarkers of intestinal permeability
(lipopolysaccharides; zonulin, citrulline, and fatty acid binding proteins).