Relationship Among Oral Microbiome and NLRP3 Inflammatome and Colorectal Polyps

December 4, 2024 updated by: Limin Zhang
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200240
        • Recruiting
        • Shanghai Fifth People's Hospital, Fudan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with colorectal polyps and Healthy controls.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Oral microbes
Time Frame: baseline
Full-length 16S rRNA sequencing was used to investigate salivary samples.
baseline
fecal microbes
Time Frame: baseline
Full-length 16S rRNA sequencing was used to investigate fecal samples.
baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
NLRP3
Time Frame: baseline
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Limin Zhang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 12, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • oral microbiome

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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