Effect of Aspirin on Gut Microbiome

NCT02761486 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 2016NTLS049
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

aspirin; gut microbiome; inflammation; placebo; circulating biomarker

Outcome Measures

Primary Outcomes (1)

• Composition of the gut microbiome

  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 Outcomes (1)

• Urinary and blood inflammatory biomarkers

  2 times within 6 weeks

Study Arms (2)

Aspirin

ACTIVE COMPARATOR

The subjects will receive 325 mg of aspirin once a day for 6 weeks followed by a 6-week washout.

Drug: Aspirin

Placebo

PLACEBO COMPARATOR

The subjects will receive placebo once a day for 6 weeks followed by a 6-week washout.

Drug: Placebo

Interventions

Aspirin DRUG

325mg aspirin per day

Also known as: Acetylsalicylic acid (ASA)

Aspirin

Placebo DRUG

placebo in matching capsules

Placebo

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

Epidemiology Clinical Research Center

Minneapolis, Minnesota, 55415, United States

Location

MeSH Terms

Conditions

Inflammation

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Anna Prizment, PhD, MPH

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2016
• First Posted: May 4, 2016
• Study Start: August 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: August 29, 2018
• Last Updated: June 26, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)