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Analysis of Blood Metabolomics to Identify Potential Biomarkers of Gastrointestinal Bleeding

Sponsor
National University, Singapore (Other)
Overall Status
Recruiting
CT.gov ID
NCT05547360
Collaborator
(none)
32
Enrollment
1
Location
5.4
Anticipated Duration (Months)
5.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Despite advances in gastrointestinal endoscopy and pharmaceuticals, gastrointestinal bleeding is still a significant emergency disease with a high mortality rate of 1.9-5 per 100 people due to excessive bleeding and shock.

There are several indicators using pulse rate, blood pressure, hemoglobin, etc. to select patients who require endoscopic intervention, or hospitalization, but these are inaccurate and with a high false-positive rate and low specificity at 35-40%.

Therefore, tests with high diagnostic accuracy for gastrointestinal bleeding patients are required and findings specific biomarkers for gastrointestinal bleeding are of great importance.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Recently, with the development of metabolomics, efforts are being made to improve the diagnosis and treatment of diseases through metabolomics analysis, but there are no studies related to gastrointestinal bleeding. If the degradation/metabolism process of blood that accumulates in the gastrointestinal tract is well studied and understood, there is a possibility of finding specific biomarkers for gastrointestinal bleeding.

    Thus, this study aims to analysis of metabolomics of blood degradation/digestion using in vitro digestion model to identify potential biomarkers of gastrointestinal bleeding.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    32 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Analysis of Metabolomics of Blood Degradation/Digestion Using in Vitro Digestion Model to Identify Potential Biomarkers of Gastrointestinal Bleeding
    Actual Study Start Date :
    Jul 19, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. blood metabolites [through study completion, an average of 5 months]

      screening of blood metabolites in digested blood (qualitative measure, untargeted analysis, using LC-qtof-MS and GC-MS)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 55 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    1. Male and female participants, aged between 21 and 55 years old.

    2. A body mass index (BMI) between 18.5 and 29.9 kilograms per meter square.

    3. English-literate and able to give informed consent in English.

    Exclusion Criteria:

    1. Smokers.

    2. Clinically significant allergic, renal, cardiac, bronchopulmonary, vascular, gastrointestinal, neurological, metabolic or immunodeficiency disorders, cancer, hepatitis, or cirrhosis.

    3. Had surgery of the gastrointestinal tract or any other medical condition considered likely to affect the gastrointestinal absorption.

    4. Use of oral iron supplement within the past 30 days.

    5. Consumes more than 2 alcoholic drinks per day i.e. one drink is defined as either 150ml of wine, 340ml of beer/cider or 45ml of distilled spirit.

    6. Significant change in weight (≥ 3 kg body weight) in the past 3 months.

    7. Significant exercise pattern over the past 3 months defined as high-intensity exercise of more than 3 hours per week.

    8. Poor peripheral venous access based on past experiences with blood draw

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National University of Singapore Singapore Singapore 117546

    Sponsors and Collaborators

    • National University, Singapore

    Investigators

    • Principal Investigator: Jung Eun Kim, Ph.D, National University of Singapore (Food Science and Technology)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jung Eun Kim, Assistant professor, National University, Singapore
    ClinicalTrials.gov Identifier:
    NCT05547360
    Other Study ID Numbers:
    • S18
    First Posted:
    Sep 21, 2022
    Last Update Posted:
    Sep 21, 2022
    Last Verified:
    Sep 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jung Eun Kim, Assistant professor, National University, Singapore
    in vitro digestion
    Metabolomics
    gastrointestinal tract
    Additional relevant MeSH terms:
    Gastrointestinal Hemorrhage
    Hemorrhage

    Study Results

    No Results Posted as of Sep 21, 2022