Influence of Aspirin on Human Gut Microbiota Composition and Metabolome

NCT03450317 | Unknown

• 1 other identifier: ASP MIC study
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Aspirin; Microbiota

Outcome Measures

Primary Outcomes (2)

• gut microbiota in stool

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

  1 year

• metabolome in biological specimens

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

  1 year

Secondary Outcomes (2)

• gut microbial composition

  1 year

• metabolomic components

  1 year

Study Arms (2)

Aspirin

EXPERIMENTAL

Aspirin 80mg once daily

Drug: Aspirin 80mg

Non-treatment group

NO INTERVENTION

No intervention

Interventions

Aspirin 80mg DRUG

No treatment

Also known as: Non-treatment

Aspirin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, ba, Hong Kong

RECRUITING

MeSH Terms

Interventions

Aspirin

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Ka Man KEE, MPH

CONTACT

+85235053855; carmenkee@cuhk.edu.hk

Rachel Ling, BSc

CONTACT

+85235053476; rachelling@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Francis Chan

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: March 1, 2018
• Study Start: March 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: August 1, 2019

Record last verified: 2019-07

Locations

HK (1)