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Staller, Kyle

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Staller

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Kyle

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Staller, Kyle

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2016 - 20173

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    ASPirin Intervention for the REDuction of colorectal cancer risk (ASPIRED): a study protocol for a randomized controlled trial
    (BioMed Central, 2017) Drew, David; Chin, Samantha M.; Gilpin, Katherine K.; Parziale, Melanie; Pond, Emily; Schuck, Madeline M.; Stewart, Kathleen; Flagg, Meaghan; Rawlings, Crystal; Backman, Vadim; Carolan, Peter; Chung, Daniel; Colizzo, Francis; Freedman, Matthew; Gala, Manish; Garber, John; Huttenhower, Curtis; Kedrin, Dmitriy; Khalili, Hamed; Kwon, Douglas S.; Markowitz, Sanford D.; Milne, Ginger L.; Nishioka, Norman; Richter, James; Roy, Hemant K.; Staller, Kyle; Wang, Molin; Chan, Andrew
    Background: Although aspirin is recommended for the prevention of colorectal cancer, the specific individuals for whom the benefits outweigh the risks are not clearly defined. Moreover, the precise mechanisms by which aspirin reduces the risk of cancer are unclear. We recently launched the ASPirin Intervention for the REDuction of colorectal cancer risk (ASPIRED) trial to address these uncertainties. Methods/design ASPIRED is a prospective, double-blind, multidose, placebo-controlled, biomarker clinical trial of aspirin use in individuals previously diagnosed with colorectal adenoma. Individuals (n = 180) will be randomized in a 1:1:1 ratio to low-dose (81 mg/day) or standard-dose (325 mg/day) aspirin or placebo. At two study visits, participants will provide lifestyle, dietary and biometric data in addition to urine, saliva and blood specimens. Stool, grossly normal colorectal mucosal biopsies and cytology brushings will be collected during a flexible sigmoidoscopy without bowel preparation. The study will examine the effect of aspirin on urinary prostaglandin metabolites (PGE-M; primary endpoint), plasma inflammatory markers (macrophage inhibitory cytokine-1 (MIC-1)), colonic expression of transcription factor binding (transcription factor 7-like 2 (TCF7L2)), colonocyte gene expression, including hydroxyprostaglandin dehydrogenase 15-(NAD) (HPGD) and those that encode Wnt signaling proteins, colonic cellular nanocytology and oral and gut microbial composition and function. Discussion Aspirin may prevent colorectal cancer through multiple, interrelated mechanisms. The ASPIRED trial will scrutinize these pathways and investigate putative mechanistically based risk-stratification biomarkers. Trial registration This protocol is registered with the U.S. National Institutes of Health trial registry, ClinicalTrials.gov, under the identifier NCT02394769. Registered on 16 March 2015. Electronic supplementary material The online version of this article (doi:10.1186/s13063-016-1744-z) contains supplementary material, which is available to authorized users.
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    New Pathways, New Targets: Visceral Hypersensitivity Pathogenesis in Irritable Bowel Syndrome
    (Nature Publishing Group, 2016) Barshop, Kenneth; Staller, Kyle
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    Associations of Bowel Movement Frequency with Risk of Cardiovascular Disease and Mortality among US Women
    (Nature Publishing Group, 2016) Ma, Wenjie; Li, Yanping; Heianza, Yoriko; Staller, Kyle; Chan, Andrew; Rimm, Eric; Rexrode, Kathryn; Qi, Lu
    Emerging evidence suggests a potential impact of gastrointestinal function on cardiometabolic risk. Abnormal bowel movements have been related to various cardiovascular risk factors such as dyslipidemia, hypertension, diabetes, and altered metabolism of bile acids and gut microbiota. However, little is known about whether bowel movement frequency affects risk of cardiovascular disease (CVD) and mortality. In the Nurses’ Health Study, bowel movement frequency was self-reported in 1982 by 86,289 women free from CVD and cancer. During up to 30 years of follow-up, we documented 7,628 incident CVD cases and 21,084 deaths. After adjustment for dietary intake, lifestyle, medication use, and other risk factors, as compared with women with daily bowel movement, having bowel movements more than once daily was significantly associated with increased risk of CVD (hazard ratio [HR]: 1.13; 95% confidence interval [CI]: 1.05–1.21), total mortality (HR: 1.17; 95% CI: 1.12–1.22), and cardiovascular mortality (HR: 1.17; 95% CI: 1.07–1.28). With further adjustment for body mass index and diabetes status, the association with total mortality remained significant (HR: 1.10; 95% CI: 1.06–1.15), whereas the associations with incident CVD and cardiovascular mortality were no longer significant. Our results suggest increased bowel movement frequency is a potential risk factor for premature mortality.