Analysis of Blood Metabolomics to Identify Potential Biomarkers of Gastrointestinal Bleeding

Analysis of Metabolomics of Blood Degradation/Digestion Using in Vitro Digestion Model to Identify Potential Biomarkers of Gastrointestinal Bleeding

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.

Study Overview

• Status: Recruiting
• Conditions: GastroIntestinal Bleeding

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 Type: Observational
• Enrollment (Anticipated): 32

Contacts and Locations

• Study Contact: Name: Jung Eun Kim, Ph.D; Phone Number: 6516 1136; Email: fstkje@nus.edu.sg
• Study Contact Backup: Name: Yuanhang Yao; Phone Number: 8308 1987; Email: yuanhang@u.nus.edu

Study Locations

• Singapore
  • Singapore, Singapore, 117546
    • Recruiting
    • National University of Singapore
    • Contact: Jung Eun Kim, Ph.D; Phone Number: 6516 1136; Email: fstkje@nus.edu.sg
    • Contact: Yuanhang Yao; Phone Number: 8308 1987; Email: yuanhang@u.nus.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study population are in general good health and not oral consuming iron supplement within the past 30 days.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood metabolites	screening of blood metabolites in digested blood (qualitative measure, untargeted analysis, using LC-qtof-MS and GC-MS)	through study completion, an average of 5 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: September 13, 2022
• First Submitted That Met QC Criteria: September 16, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 16, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Metabolomics; gastrointestinal tract; in vitro digestion
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage
• Other Study ID Numbers: S18

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No