40
Participants
Start Date
September 1, 2022
Primary Completion Date
June 30, 2025
Study Completion Date
December 28, 2025
Venipuncture
Draw of peripheral blood (about 20 ml and 40 ml, during the screening and procedure visits, respectively).
Targeted physical medical exam
"Study participants will be undergoing a physical exam where vitals will be recorded (e.g. temperature, blood pressure, heart rate). The registered nurse (RN) will also perform auscultation of heart and lungs.~Study participants will be also asked to fill out a survey with questions related to his/her medical history, current use of medications, sexual history and substance abuse."
Urine pregnancy test
Women of childbearing potential will be asked to run an urine pregnancy test during the second (procedure) visit. Pregnant women will not be allowed to participate in the study.
Anoscopy
The anoscopy is an examination using a small, rigid, tubular instrument called anoscope (also called an anal speculum). This is inserted a few inches into the rectum in order to collect some small samples of mucosal tissue. We will collect 5 rectum biopsy samples and one cytobrush.
Esophagogastroduodenoscopy (EGD)
The EGD involves looking at the esophagus, stomach, and first and second portion of the duodenum. This procedure involves the use of an endoscope to remove small tissue samples. This procedure uses conscious sedation drugs given by a vein in the arm. The procedure takes about 1½-2 hours, including time for recovery. We will collect 5 duodenal biopsies and one cytobrush.
University of Washington Positive Research and the Gastroenterology Clinic at Harborview Medical Center, Seattle
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
National Center for Advancing Translational Sciences (NCATS)
NIH
University of Washington
OTHER