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
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Aspirin Drug: Placebo||Phase 1|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|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|
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 Name: Acetylsalicylic acid (ASA)
Placebo Comparator: Placebo
The subjects will receive placebo once a day for 6 weeks followed by a 6-week washout.
placebo in matching capsules
- 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).
- 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.
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
|United States, Minnesota|
|Epidemiology Clinical Research Center|
|Minneapolis, Minnesota, United States, 55415|
|Principal Investigator:||Anna Prizment, PhD, MPH||University of Minnesota - Clinical and Translational Science Institute|