Changes of Muramyl Dipeptide in Intestinal and Extra-intestinal Diseases

• Sponsor: Zhujiang Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04924686
• Collaborator: National Natural Science Foundation of China (Other)
• Enrollment: 600
• Location: 1
• Anticipated Duration (Months): 39.2
• Patients Per Site Per Month: 15.3

Study Details

Study Description

Brief 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 ).

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer; Inflammatory Bowel Disease; Atherosclerotic Cardiovascular Disease; Type2 Diabetes Mellitus	Other: Observational studies, no intervention

Detailed 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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 600 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• Official Title: A Bacterial Bi-functional Peptidoglycan Hydrolase Sheds NOD2 Ligands to Regulate Gut Homeostasis
• Actual Study Start Date: May 10, 2020
• Anticipated Primary Completion Date: Jun 10, 2023
• Anticipated Study Completion Date: Aug 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Crohn's disease The fecal and plasma were collected	Other: Observational studies, no intervention; Observational studies, no intervention
Ulcerative colitis The fecal and plasma were collected	Other: Observational studies, no intervention; Observational studies, no intervention
Diabetes mellitus, type 2 The fecal and plasma were collected	Other: Observational studies, no intervention; Observational studies, no intervention
Atherosclerotic cardiovascular disease The fecal and plasma were collected	Other: Observational studies, no intervention; Observational studies, no intervention
Colorectal cancer The fecal and plasma were collected	Other: Observational studies, no intervention; Observational studies, no intervention

Outcome Measures

Primary Outcome Measures

1. NOD2 ligands in fecal and plasma [baseline]

   detected using targeted metabolomics (LC-MS-MS methods) and NOD2-transfected cells co-expressing NF-κB luciferase reporters

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhujiang hospital	Guangzhou	Guang Dong	China	510000

Sponsors and Collaborators

• Zhujiang Hospital
• National Natural Science Foundation of China

Investigators

• Principal Investigator: Hongwei Zhou, professor, Zhujiang Hospital, Guangzhou, Guangdong

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Hongwei Zhou, Proffessor, Zhujiang Hospital
• ClinicalTrials.gov Identifier: NCT04924686
• Other Study ID Numbers: ZhujiangH-1
• First Posted: Jun 14, 2021
• Last Update Posted: Jun 14, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hongwei Zhou, Proffessor, Zhujiang Hospital: NOD2 ligands
• Additional relevant MeSH terms: Inflammatory Bowel Diseases; Cardiovascular Diseases; Atherosclerosis; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jun 14, 2021