Effect of Aspirin on Gut Microbiome

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

Regular use of aspirin may reduce the incidence of colorectal cancer (CRC). However, it is unclear through which mechanism aspirin exerts its effect, in whom it decreases CRC risk and in whom it causes side effects. Recently, the imbalanced gut microbiome was linked to inflammation and CRC risk. The main hypothesis for this study is that aspirin may decrease CRC risk via targeting the gut microbiome. The study will be a randomized placebo-controlled double-blinded design, recruiting 50 healthy subjects, 50-75 years old, from the PRospective Evaluation of SEPTin 9 (PRESEPT) cohort living in the greater Twin Cities area, who will receive either aspirin or placebo for 6 weeks.

Key facts

Study ID

NCT02761486

Run by

University of Minnesota

People needed

50

Starts

2016-08-01

Expected to finish

2018-08-29

Last updated by the study team

2020-06-26

Who can join

Age: 50 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy adults aged 50-75 years who reside within the greater Twin Cities area
• Capable and willing to comply with the entire study protocol
• Able to give voluntary written informed consent.

You may not qualify if…

• Use of any aspirin-containing products or other non-steroidal anti-inflammatory drugs (NSAIDs) (≥ 2 days per week on a regular basis)
• Known hypersensitivity to NSAIDs
• Any active cancer, history of gastrointestinal cancer, or chronic disease such as peptic ulcer, irritable bowel syndrome, inflammatory bowel disease, intestinal malabsorption syndrome or other gastrointestinal disorder
• History of any coagulation, bleeding, or blood disorders (e.g. Anemia)
• History of stroke/ Transient Ischemic Attack
• Acute heart disease or history of heart attack, atrial fibrillation, or angina
• Diagnosis of dementia
• Use of antibiotics, antiplatelets (e.g. clopidogrel), or anticoagulants (e.g. warfarin) within the last 3 months. A complete list of contraindicated medications will be provided (Appendix A)
• Regular use of laxatives (e.g. Ex-lax, Dulcolax, Miralax) that may affect the microbiome ≥2 days a week (Appendix B)
• Body mass index (BMI) greater than or equal to 40 or less than or equal to 17 kg/m2 at screening visit
• Unexplained change in weight (>4.5 kg) within the past 6 months
• Major changes in eating habits within the past 3 months

Where it is running

• Epidemiology Clinical Research Center — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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