Analysis of Cellular Kinases and Aging in PBMCs and Colorectal Tissue (NCT06132386) | Clinical Trial Compass
CompletedNot Applicable
Analysis of Cellular Kinases and Aging in PBMCs and Colorectal Tissue
United States21 participantsStarted 2023-08-07
Plain-language summary
The goal of this clinical study is to learn about the effect of aging on certain enzymes, or proteins, in the blood and colon. The study involves collection of blood and colon tissue biopsies using a flexible sigmoidoscope or colonoscope. This study is also investigating how medications tenofovir and emtricitabine interact with certain enzymes. The investigators will compare the difference in enzyme activity between people taking tenofovir and emtricitabine, to those who are not taking tenofovir and emtricitabine.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. English speaking male or female volunteers between the ages of 18-50 for younger adults or 65-80 for older adults
✓. Willing to provide written informed consent
✓. Willing to abstain from insertion of anything in rectum for 72 hours before and 72 hours after the endoscopic procedure for colorectal tissue collection.
✓. Not currently participating in other research studies involving drugs and/or medical devices.
✓. No known risk for HIV exposure or a documented negative HIV-1/HIV-2 Ag/Ab test in the past 3 months (HIV risk, but not on PrEP)
✓. Documented negative HBsAg in those taking study TFV (i.e. cohort B)
✓. Currently taking TFV-based oral PrEP daily or willing to take oral TFV-containing PrEP for one week
✓. Documented negative HIV-1/HIV-2 Ag/Ab test in the past 3 months
Exclusion criteria
✕. History of inflammatory bowel disease or active inflammatory condition of the GI tract
✕. History of significant gastrointestinal bleeding
✕. Current medically-indicated use of warfarin or heparin or other anticoagulant medications associated with increased risk for bleeding following mucosal biopsy (e.g., daily high dose aspirin \[\>81 mg\], non-steroidal anti-inflammatory drugs \[NSAIDs\], or Pradaxa®)
What they're measuring
1
Concentration of AK2 in Colorectal Tissue
Timeframe: Once within one month
2
Concentration of CKM in Colorectal Tissue
Timeframe: Once within one month
3
Concentration of AK2 in Peripheral Blood Mononuclear Cells
. Use of systemic immunomodulatory medications within 4 weeks of enrollment
✕. Use of rectally administered medications within 4 weeks of enrollment
✕. Use of product containing nonoxynol-9 within 4 weeks of enrollment
✕. Use of any investigational products within 4 weeks of enrollment
✕. Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to comply with the study requirements. Such conditions may include, but are not limited to, current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, or cerebral disease.