AspirinNCT03450317
Influence of Aspirin on Human Gut Microbiota Composition and Metabolome
A study testing Aspirin 80mg in people with Aspirin and Microbiota, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aspirin, Microbiota
- What is being tested?
- Aspirin 80mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Mar 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Hong Kong, ba
About this study
Official title: The Influence of Aspirin on Human Gut Microbiota Composition and Metabolome: Contributing to the Therapeutic Effects of the Drug
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.
- Conditions
- Aspirin, Microbiota
- Being tested
- Aspirin 80mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin 80mgDrug
Also called Non-treatment
No treatment
| Study group | Role | What they receive |
|---|---|---|
| Aspirin | Experimental | Aspirin 80mg once daily Receives: Drug: Aspirin 80mg |
| Non-treatment group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
gut microbiota in stool
To capture the fingerprint of gut microbiota in stool before and after oral administration of aspirin
Measured: 1 year
metabolome in biological specimens
To capture the metabolome in biological specimens before and after oral administration of aspirin
Measured: 1 year
Secondary outcomes (2)
gut microbial composition
To profile the alteration of gut microbial composition by aspirin
Measured: 1 year
metabolomic components
To profile the alteration of the metabolomic components by aspirin
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start1 Mar 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AspirinStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francis KL Chan, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450317
- Sponsor's protocol ID
- ASP MIC study
- Status last verified
- Jul 2019
- First submitted
- 22 Feb 2018
- Last updated
- 1 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Aspirin on Human Gut Microbiota Composition and Metabolome: Contributing to the Therapeutic Effects of the Drug
- ClinicalTrials.gov ID
- NCT03450317
- Acronym / sponsor ID
- ASP MIC study
- Conditions
- Aspirin, Microbiota
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 1 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin | Experimental | Drug: Aspirin 80mgAspirin 80mg once daily |
| Non-treatment group | No intervention | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin 80mgAlso: Non-treatmentNo treatment | Drug | Aspirin |
Primary outcome
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
2 secondary outcomes
gut microbial composition
Time frame: 1 year
metabolomic components
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
Related trials for Aspirin
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
RecruitingPhase 2
A Phase IIa Randomized, Double-Blinded Clinical Trial of Naproxen or Aspirin for Cancer Immune Interception in Lynch Syndrome
T Cells, Colorectal Cancer
Active, not recruitingPhase 2/3
Regorafenib With Low-dose Chemotherapies and Aspirin Followed by Standard Chemotherapies in Metastatic Colorectal Cancer
Metastatic Colorectal Cancer
RecruitingPhase 3
The Efficacy of Aspirin Combined With Hydroxychloroquine Treatment in High Risk Pregnancies for Preeclampsia
Preeclampsia
Not yet recruitingPhase 3
Aspirin for the Prevention of Ischemic Complications in Giant Cell Arteritis
Giant Cell Arteritis (GCA), Acute Coronary Syndrome (ACS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspirin 80mg in people with Aspirin and Microbiota, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ka Man KEE, MPH (+85235053855, carmenkee@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gut microbiota in stool (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2019.