Relationship Among Oral Microbiome and NLRP3 Inflammatome and Colorectal Polyps

ConditionSearch MeSH
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLimin Zhang

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Patients diagnosed with colorectal polyps and Healthy controls.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

80 Participants
are grouped into 2 trial groups
Group A: Case group
Group B: Control group

Trial outcomes

Primary outcomes

1

Oral microbes

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

Time frame
baseline
2

fecal microbes

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

Time frame
baseline

Secondary outcomes

1

NLRP3

Time frame
baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Limin Zhang

Lead sponsor

Shanghai 5th People's Hospital

Sponsor institution