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Influence of Aspirin on Human Gut Microbiota Composition and Metabolome

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ClinicalTrials.gov Identifier: NCT03450317
Recruitment Status : Recruiting
First Posted : March 1, 2018
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
Francis KL Chan, Chinese University of Hong Kong

Brief Summary:

Colorectal cancer (CRC) is the third most common cancer type in males and the second in females, accounting for about 693,900 deaths worldwide per year. Although the annual CRC mortality rate is still very high, it demonstrated a decline by 47% among men and 44% among women from 1990 to 2015. This decreasing trend may be attributed to improved screening, early detection as well as combined CRC treatment. In fact, the mortality rate is expected to reduce further by long-term use of chemopreventive agents that can prevent the development of neoplasms in the large bowel. Several decades of research both in clinic and laboratory has identified aspirin as an effective synthetic CRC chemoprevention drug.

It is commonly accepted that aspirin exerts its chemopreventive effects by inhibiting catalytic enzymes cyclooxygenase (COX) -1 and COX-2 involved in prostaglandin synthesis. But the mechanism of its chemopreventive effect on CRC is not clearly understood. Other than CRC, aspirin also showed its potential inhibitory effects on some other types of solid cancer, such as pancreatic, lung, breast and prostate cancers. However, its effects on extragastrointestinal cancer types are still elusive due to lack of reliable supporting evidence from randomized clinical trials. Based on current knowledge, it is unclear why aspirin appears to inhibit CRC more than other cancers. This might be associated with the unique microenvironment comprising trillions of microbes in which CRC resides.


Condition or disease Intervention/treatment Phase
Aspirin Microbiota Drug: Aspirin 80mg Not Applicable

Detailed Description:

Colorectal cancer (CRC) is the third most common cancer type in males and the second in females, accounting for about 693,900 deaths worldwide per year.

It is commonly accepted that aspirin exerts its chemopreventive effects by inhibiting catalytic enzymes cyclooxygenase (COX) -1 and COX-2 involved in prostaglandin synthesis.This hypothetic mechanism is supported by clinical data from two large cohorts that found that the regular use of aspirin reduced the risk of CRC with high expression of COX-2 but not with low or no expression of COX-2.

Based on current knowledge, it is unclear why aspirin appears to inhibit CRC more than other cancers. This might be associated with the unique microenvironment comprising trillions of microbes in which CRC resides. Therefore, the investigator hypothesizes that there is a link between the chemopreventive mechanism of aspirin, gut microbiota as well as the metabolome.

During the past decade, evidence has accumulated that microbiota in the host is highly sensitive to the gut microenvironment since its composition and activity can be rapidly and reproducibly changed by diet or nutrients. As such, an acidic drug like aspirin may be able to alter the gut microbiota composition. It is thus conceivable that the CRC preventive action of aspirin may be through the alteration of host gut microbes.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Influence of Aspirin on Human Gut Microbiota Composition and Metabolome: Contributing to the Therapeutic Effects of the Drug
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: Aspirin
Aspirin 80mg once daily
Drug: Aspirin 80mg
No treatment
Other Name: Non-treatment

No Intervention: Non-treatment group
No intervention



Primary Outcome Measures :
  1. gut microbiota in stool [ Time Frame: 1 year ]
    To capture the fingerprint of gut microbiota in stool before and after oral administration of aspirin

  2. metabolome in biological specimens [ Time Frame: 1 year ]
    To capture the metabolome in biological specimens before and after oral administration of aspirin


Secondary Outcome Measures :
  1. gut microbial composition [ Time Frame: 1 year ]
    To profile the alteration of gut microbial composition by aspirin

  2. metabolomic components [ Time Frame: 1 year ]
    To profile the alteration of the metabolomic components by aspirin



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • NSAID naïve during the last month;
  • absence of drugs, nutrient supplements, probiotics, prebiotics and synbiotics that might interfere with microbial homeostasis for all participants;
  • no past history of gastrointestinal bleeding or ulcers;
  • absence of historical aspirin-induced side effects;
  • voluntary and willing to cooperate during treatment; and
  • consent with treatment and sample collection schedule

Exclusion Criteria:

  • unfit symptoms, such as epigastric pain, acid reflux, eructation and dyspepsia;
  • diagnosis of any disease during the past 3 months;
  • diarrhea within the previous 7 days;
  • history of alcohol abuse, defined as >80 g/d in men and >40 g/d in women;
  • pregnancy; and
  • mental illness rendering the participants unable to understand the nature, scope, and possible consequences of the study

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): NCT03450317


Contacts
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Contact: Ka Man KEE, MPH +85235053855 carmenkee@cuhk.edu.hk
Contact: Rachel Ling, BSc +85235053476 rachelling@cuhk.edu.hk

Locations
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Hong Kong
Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong, ba
Sponsors and Collaborators
Chinese University of Hong Kong

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Responsible Party: Francis KL Chan, Prof. Francis Chan, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03450317     History of Changes
Other Study ID Numbers: ASP MIC study
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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