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
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
Aspirin 80mg once daily
Drug: Aspirin 80mg
Other Name: Non-treatment
No Intervention: Non-treatment group
- gut microbiota in stool [ Time Frame: 1 year ]To capture the fingerprint of gut microbiota in stool before and after oral administration of aspirin
- metabolome in biological specimens [ Time Frame: 1 year ]To capture the metabolome in biological specimens before and after oral administration of aspirin
- gut microbial composition [ Time Frame: 1 year ]To profile the alteration of gut microbial composition by aspirin
- metabolomic components [ Time Frame: 1 year ]To profile the alteration of the metabolomic components by aspirin
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
|Contact: Ka Man KEE, MPHfirstname.lastname@example.org|
|Contact: Rachel Ling, BScemail@example.com|
|Prince of Wales Hospital||Recruiting|
|Hong Kong, Hong Kong, ba|