Relationship Among Oral Microbiome and NLRP3 Inflammatome and Colorectal Polyps

NCT06724133 | Recruiting DMC

• 1 other identifier: oral microbiome
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, a case-control study was intended to establish a model for the combined diagnosis of colorectal polyps by detecting the expressions of oral and intestinal flora, ASC, Caspase-1, IL-1β and IL-18 in patients with colorectal polyps and healthy controls, as well as peripheral venous blood and intestinal tissue. To analyze the correlation between oral and intestinal specific flora and host inflammatory status, and explore the correlation between oral and intestinal flora, NLRP3 inflammatory complex, and colorectal polyps (pin-pin-two correlation), with a view to providing new biomarkers for the diagnosis and prognosis assessment of colorectal polyps from the perspective of oral and intestinal microorganisms and host immune inflammatory response. It also provides a new targeted treatment strategy for clinical prevention and treatment, and actively prevents the occurrence and development of colorectal polyp canceration.

Conditions

Search MeSH

Outcome Measures

Primary Outcomes (2)

• Oral microbes

  Full-length 16S rRNA sequencing was used to investigate salivary samples.

  baseline

• fecal microbes

  Full-length 16S rRNA sequencing was used to investigate fecal samples.

  baseline

Secondary Outcomes (1)

• NLRP3

  baseline

Study Arms (2)

Case group

Patients diagnosed with colorectal polyps by enteroscopy in the gastroenterology department of our hospital were collected. For patients with two or more different types of histopathological examination results, all cases containing tubular adenoma, tubular villous adenoma and villous adenoma were classified into the adenoma group.

Control group

Age - and sex-matched family members of the patient were selected, and no enteric-related diseases were detected by colonoscopy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with colorectal polyps and Healthy controls.

You may qualify if:

• Case group: Patients diagnosed with colorectal polyps by enteroscopy in the gastroenterology department of our hospital were collected. For patients with two or more different types of histopathological examination results, all cases containing tubular adenoma, tubular villous adenoma and villous adenoma were classified into the adenoma group.
• Control group: Age - and sex-matched family members of the patient were selected, and no enteric-related diseases were detected by colonoscopy.

You may not qualify if:

• a) The patient refuses to participate in the program; b) The patient has cognitive impairment and cannot cooperate with the researcher; c) Patients diagnosed with familial adenomatous polyposis or hereditary non-polyposis colorectal cancer, or with obvious familial genetic predisposition in the family, combined with other digestive system diseases and anorectal diseases; d) Infectious diseases; Such as respiratory tract, digestive tract, urinary system, reproductive system acute and chronic infection; e) Patients with a history of systemic disease: patients with serious lesions of heart, brain, liver, kidney and other important organs, such as organ dysfunction: cirrhosis, kidney failure, etc. (patients with severe heart, liver, and renal insufficiency); f) Immune diseases: such as connective tissue diseases, rheumatoid arthritis, etc.; g) Diseases of the blood system (have primary dyslipidemia, or have taken lipid-regulating drugs in the past 3 months); h) Patients with malignant tumors who have received radiotherapy and chemotherapy; i) a BMI of less than 18.5kg/m2 or a BMI of more than 32kg/m2 or severe malnutrition; j) Chronic metabolic diseases such as diabetes mellitus (including type 1 and type 2) and gout; k) Patients with a history of gastrointestinal surgery, or a history of intestinal surgery due to polyps or tumors; l) Pregnant and lactating women; m) Patients with edentulous jaws; n) Patients with a history of periodontal treatment in the past 6 months; o) Patients with fixed appliances in the mouth; p) Use probiotics, microbiotics, antibiotics, metformin, proton pump inhibitors, berberine and cathartic agents within the past 1 month.

Sponsors & Collaborators

• Limin Zhang: lead

Study Sites (1)

Shanghai Fifth People's Hospital, Fudan University

Shanghai, Shanghai Municipality, 200240, China

RECRUITING

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: May 12, 2021
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)