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Effect of Aspirin on Gut Microbiome (ASMIC)

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ClinicalTrials.gov Identifier: NCT02761486
Recruitment Status : Completed
First Posted : May 4, 2016
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Aspirin Drug: Placebo Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Pilot Trial to Examine the Effect of Aspirin on the Gut Microbiome
Actual Study Start Date : August 2016
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : August 29, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

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.
Drug: Aspirin
325mg aspirin per day
Other Name: Acetylsalicylic acid (ASA)

Placebo Comparator: Placebo
The subjects will receive placebo once a day for 6 weeks followed by a 6-week washout.
Drug: Placebo
placebo in matching capsules




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02761486


Locations
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United States, Minnesota
Epidemiology Clinical Research Center
Minneapolis, Minnesota, United States, 55415
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
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Principal Investigator: Anna Prizment, PhD, MPH University of Minnesota - Clinical and Translational Science Institute

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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02761486     History of Changes
Other Study ID Numbers: 1604M86161
2016NTLS049 ( Other Identifier: UMN Clinical Protocol Review Committee )
First Posted: May 4, 2016    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No. The results of the study will be disseminated to various stakeholders through the publication of a manuscript in a peer-reviewed journal and through presentation at scientific meetings.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
aspirin
gut microbiome
inflammation
placebo
circulating biomarker

Additional relevant MeSH terms:
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Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics