ClinicalTrials.gg
Status unknownNCT03450317Updated Aug 1, 2019

Influence of Aspirin on Human Gut Microbiota Composition and Metabolome

An interventional study of Aspirin 80mg in Aspirin and Microbiota, sponsored by Chinese University of Hong Kong. Status unknown at 1 site in Hong Kong. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-01.

Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Aspirin
  • Microbiota
03

In context

Lead sponsor

Chinese University of Hong Kong is the lead sponsor of 1,454 studies on the registry; 474 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Aspirin

    Aspirin 80mg once daily

    Drug: Aspirin 80mg

  • No intervention
    Non-treatment group

    No intervention

Interventions

06

What researchers measure

Primary outcomes

  1. gut microbiota in stool

    To capture the fingerprint of gut microbiota in stool before and after oral administration of aspirin

    Time frame: 1 year

  2. metabolome in biological specimens

    To capture the metabolome in biological specimens before and after oral administration of aspirin

    Time frame: 1 year

Secondary outcomes

  1. gut microbial composition

    To profile the alteration of gut microbial composition by aspirin

    Time frame: 1 year

  2. metabolomic components

    To profile the alteration of the metabolomic components by aspirin

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Prince of Wales Hospital
    Hong Kong, ba, Hong Kong
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03450317
Responsible party
Francis KL Chan (Prof. Francis Chan, Chinese University of Hong Kong) — Principal investigator
First posted
Mar 1, 2018
Start date
Mar 1, 2018
Primary completion
Dec 31, 2020 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
Aug 1, 2019

Study contacts

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

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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