Exploring the link between oral bacteria and colorectal polyps
Relationship Among Oral Microbiome and NLRP3 Inflammatome and Colorectal Polyps
This study is trying to see if the bacteria in your mouth are linked to colorectal polyps and if they can help find new ways to prevent these polyps from turning into cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai 5th People's Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06724133 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the relationship between the oral microbiome and the NLRP3 inflammasome in patients with colorectal polyps compared to healthy controls. By analyzing the expressions of oral and intestinal flora, as well as inflammatory markers in blood and intestinal tissue, the study seeks to identify potential biomarkers for diagnosing and assessing the prognosis of colorectal polyps. The findings may lead to new targeted treatment strategies for preventing the progression of colorectal polyps to cancer.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with colorectal polyps and their age- and sex-matched family members without enteric-related diseases.
Not a fit: Patients with hereditary colorectal cancer syndromes or significant cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new diagnostic tools and treatment strategies for colorectal polyps, potentially reducing the risk of colorectal cancer.
How similar studies have performed: While the specific approach of linking oral microbiome and colorectal polyps is novel, similar studies have shown promising results in understanding the role of microbiomes in various diseases.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai Fifth People's Hospital, Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.