Changes of Muramyl Dipeptide in Intestinal and Extra-intestinal Diseases

Colorectal Cancer Clinical Trial

Official title:

A Bacterial Bi-functional Peptidoglycan Hydrolase Sheds NOD2 Ligands to Regulate Gut Homeostasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04924686
• Other study ID #: ZhujiangH-1
• Status: Recruiting
• Start date: May 10, 2020
• Est. completion date: August 15, 2023

Study information

• Verified date: June 2021
• Source: Zhujiang Hospital
• Contact: Jie Gao, PHD
• Phone: 15625043043
• Email: 994856235[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Nucleotide-binding oligomerization domain 2 (Nod2) signaling is critical for human health.To figure out the clinical relevance of NOD2 ligands, the investigators plan to evaluate the change of NOD2 ligands in inflammatory bowel diseases (IBD), CRC, atherosclerotic cardiovascular disease (ACVD), and type 2 diabetes mellitus (DM2 ).

Description:

Previous studies have shown that NOD2 gene mutants were associated with the Crohn's disease (CD), colorectal cancer (CRC) and many other diseases, suggesting the critical role of NOD2 signaling in human physiology and pathogenethesis. However, whether decreased NOD2 ligands also contributed to these diseases is unknown. In this study, the investigators plan to evaluate the change of NOD2 ligands in inflammatory bowel diseases (IBD), CRC, atherosclerotic cardiovascular disease (ACVD), and type 2 diabetes mellitus (DM2 ). For each of the patient, a sex- and age- matched control were chosen. Both the targeted metabolomics (LC-MS-MS methods) and NOD2-transfected cells co-expressing NF-κB luciferase reporters were used to test NOD2 ligands in the fecal and plasma samples.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: August 15, 2023
• Est. primary completion date: June 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Males or females at least 18-70 years old.

2. Patient able to give informed consent.

3. Patient with biopsy-proven CRC

4. Patient with biopsy-proven Crohn's disease (CD) or ulcerative colitis(UC), in the active phase.

5. patients with clinical diagnosed DM2

6. patients with ACVD:coronary angiography more than 50% stenosis in single or multiple vessels.

7. The age- and sex- matched health controls for each patient.

Exclusion Criteria:

1.Use antibiotics or probiotics within the last 2 weeks.

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerotic Cardiovascular Disease
• Cardiovascular Diseases
• Colorectal Cancer
• Diabetes Mellitus, Type 2
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Type2 Diabetes Mellitus

Intervention

Other:
• Observational studies, no intervention
Observational studies, no intervention

Locations

Country	Name	City	State
China	Zhujiang hospital	Guangzhou	Guang Dong

Sponsors (2)

Lead Sponsor	Collaborator
Zhujiang Hospital	National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

References & Publications (1)

Philpott DJ, Sorbara MT, Robertson SJ, Croitoru K, Girardin SE. NOD proteins: regulators of inflammation in health and disease. Nat Rev Immunol. 2014 Jan;14(1):9-23. doi: 10.1038/nri3565. Epub 2013 Dec 13. Review. Erratum in: Nat Rev Immunol. 2014 Feb;14(2):131. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NOD2 ligands in fecal and plasma	detected using targeted metabolomics (LC-MS-MS methods) and NOD2-transfected cells co-expressing NF-?B luciferase reporters	baseline