Analysis of Blood Metabolomics to Identify Potential Biomarkers of Gastrointestinal Bleeding

NCT05547360 | Unknown

• 1 other identifier: S18
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

GastroIntestinal Bleeding

Keywords

in vitro digestion; Metabolomics; gastrointestinal tract

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Male and female participants, aged between 21 and 55 years old.
• A body mass index (BMI) between 18.5 and 29.9 kilograms per meter square.
• English-literate and able to give informed consent in English.

You may not qualify if:

• Smokers.
• Clinically significant allergic, renal, cardiac, bronchopulmonary, vascular, gastrointestinal, neurological, metabolic or immunodeficiency disorders, cancer, hepatitis, or cirrhosis.
• Had surgery of the gastrointestinal tract or any other medical condition considered likely to affect the gastrointestinal absorption.
• Use of oral iron supplement within the past 30 days.
• 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.
• Significant change in weight (≥ 3 kg body weight) in the past 3 months.
• Significant exercise pattern over the past 3 months defined as high-intensity exercise of more than 3 hours per week.
• Poor peripheral venous access based on past experiences with blood draw

Sponsors & Collaborators

• National University of Singapore: lead

Study Sites (1)

National University of Singapore

Singapore, 117546, Singapore

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jung Eun Kim, Ph.D

  National University of Singapore (Food Science and Technology)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jung Eun Kim, Ph.D

CONTACT

6516 1136; fstkje@nus.edu.sg

Yuanhang Yao

CONTACT

8308 1987; yuanhang@u.nus.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 21, 2022
• Study Start: July 19, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: September 21, 2022

Record last verified: 2022-09

Locations

SG (1)