Search MeSHNCT06724133
Relationship Among Oral Microbiome and NLRP3 Inflammatome and Colorectal Polyps
An observational study of Search MeSH, run by Limin Zhang at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Search MeSH
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 12 May 2021to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients diagnosed with colorectal polyps and Healthy controls.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Fifth People's Hospital, Fudan University
Shanghai, Shanghai Municipality, 200240
Limin Zhang, postgraduate, 15921173946, minlizhang1993@126.com
About this study
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Oral microbes
Full-length 16S rRNA sequencing was used to investigate salivary samples.
Measured: baseline
fecal microbes
Full-length 16S rRNA sequencing was used to investigate fecal samples.
Measured: baseline
Secondary outcomes (1)
NLRP3
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start12 May 2021
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Search MeSHStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Limin Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Limin Zhang, Shanghai 5th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06724133
- Sponsor's protocol ID
- oral microbiome
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Among Oral Microbiome and NLRP3 Inflammatome and Colorectal Polyps
- ClinicalTrials.gov ID
- NCT06724133
- Acronym / sponsor ID
- oral microbiome
- Conditions
- Search MeSH
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Limin ZhangUniversity, hospital or other
- Study start
- 12 May 2021 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with colorectal polyps and Healthy controls.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Oral microbes
Time frame: baseline
Full-length 16S rRNA sequencing was used to investigate salivary samples.
fecal microbes
Time frame: baseline
Full-length 16S rRNA sequencing was used to investigate fecal samples.
1 secondary outcome
NLRP3
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: Yes
Related trials for Search MeSH
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Search MeSH, run by Limin Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral microbes (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.