- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02761486
Effect of Aspirin on Gut Microbiome (ASMIC)
Pilot Trial to Examine the Effect of Aspirin on the Gut Microbiome
Study Overview
Detailed Description
The pilot study will evaluate the feasibility of conducting a large randomized trial and estimate the effects of aspirin on the gut microbiome. The study will recruit 50 healthy subjects, 50-75 years old, from the PRospective Evaluation of SEPTin 9 (PRESEPT) cohort living in the greater Twin Cities area.
The Primary Aim is to 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 randomized placebo-controlled double-blinded design, i.e. examine the change of microbiome over time within and between the subjects. The hypothesis for this aim is that in the aspirin arm versus the placebo arm, gut microbiome composition will shift towards a lower proportion of pro-inflammatory, CRC-predisposing bacteria (e.g. Fusobacteria) and higher proportion of anti-inflammatory, CRC-protective bacteria (e.g. butyrate-producing bacteria).
The Secondary Aims are to examine the correlation between the aspirin-related changes in microbiome profile with the levels of circulating inflammatory biomarkers in urine and plasma. Within-individual and between-arm differences in microbiome composition will be compared after 3 and 6 weeks of aspirin intake. Also, the microbiome composition will be compared after 3-week and 6-week wash-out periods to test whether these periods are sufficient to restore gut microbiome composition to a pre-treatment level. This study will inform future crossover randomized studies focusing on CRC preventive interventions that will enable clinicians to identify optimal candidates for aspirin therapy for the purposes of CRC prevention using this accessible and cheap drug.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55415
- Epidemiology Clinical Research Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Aspirin
The subjects will receive 325 mg of aspirin once a day for 6 weeks followed by a 6-week washout.
|
325mg aspirin per day
Other Names:
|
Placebo Comparator: Placebo
The subjects will receive placebo once a day for 6 weeks followed by a 6-week washout.
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placebo in matching capsules
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composition of the gut microbiome
Time Frame: 5 times within 12 weeks
|
Fecal microbial diversity and the prevalence of specific taxa associated with colorectal cancer (e.g.
Fusobacteria, butyrate producing bacteria) will be estimated at each time point.
The aspirin-related changes in the prevalence of each taxon will be assessed individually and also combined into a microbiome index (the abundance of protective taxa will be included as a negative value).
|
5 times within 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urinary and blood inflammatory biomarkers
Time Frame: 2 times within 6 weeks
|
Each inflammatory biomarker (e.g.
urinary metabolite of Prostaglandin E2 (PGE2)) will be measured before and after treatment with aspirin.
Changes in inflammatory markers will be correlated to changes in the microbial diversity and the microbiome index.
|
2 times within 6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anna Prizment, PhD, MPH, University of Minnesota
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Aspirin
Other Study ID Numbers
- 2016NTLS049 (Other Identifier: UMN Clinical Protocol Review Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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