Analysis of Blood Metabolomics to Identify Potential Biomarkers of Gastrointestinal Bleeding

GastroIntestinal Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05547360
• Other study ID #: S18
• Status: Recruiting
• Start date: July 19, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2022
• Source: National University, Singapore
• Contact: Jung Eun Kim, Ph.D
• Phone: 6516 1136
• Email: fstkje[@]nus.edu.sg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• GastroIntestinal Bleeding
• Gastrointestinal Hemorrhage
• Hemorrhage

Locations

Country	Name	City	State
Singapore	National University of Singapore	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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