This pilot clinical trial studies the effects of aspirin on the gut microbiome in healthy volunteers. Aspirin may affect the bacteria that live in the intestine and lower the risk of colorectal cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT02761486.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. Estimate the impact of a 3- and 6-week intake of once daily 325 mg aspirin on the composition of the gut microbiome using a pre-post test design, i.e. examine the change of microbiome over time within the subjects.
SECONDARY OBJECTIVES:
I. Examine the correlation between the aspirin-related changes in microbiome profile with the levels of circulating biomarkers: urinary PGE-M and plasma MIC-1.
II. Estimate whether within-individual microbiome composition will be similar after 3 and 6 weeks of aspirin intake.
III. Determine whether a 3-week wash-out period is sufficient to restore gut microbiome composition to a pre-treatment level.
OUTLINE:
Patients receive aspirin orally (PO) once daily (QD) for 6 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study, patients are followed up for 6 weeks.
Trial PhaseNo phase specified
Trial Typebasic science
Lead OrganizationUniversity of Minnesota/Masonic Cancer Center
Principal InvestigatorAnna Prizment