Oral microbiota patterns in chronic and autoimmune pancreatitis
The Characteristics of Oral Microbiota in Chronic Pancreatitis and Autoimmune Pancreatitis
Ruijin Hospital · NCT07015580
We will sequence mouth bacteria to see if people with chronic pancreatitis or autoimmune pancreatitis have different oral microbiota.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 360 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ruijin Hospital (other) |
| Locations | 1 site (Shanghai, Shanghai, China) |
| Trial ID | NCT07015580 on ClinicalTrials.gov |
What this trial studies
This observational study will collect saliva and oral swab samples from people with chronic pancreatitis and autoimmune pancreatitis and use full-length 16S rRNA sequencing to profile their oral bacterial communities. Participants who used antibiotics or immunosuppressants within 30 days, have recent digestive surgery, are pregnant or lactating, have other gastrointestinal diseases, or take daily probiotics will be excluded. Researchers will analyze species composition, diversity measures, and specific taxa to identify patterns associated with pancreatitis subtypes and pancreatic disease. The work addresses a gap in prior research that has focused mostly on gut microbiota rather than the mouth.
Who should consider this trial
Good fit: Ideal candidates are adults with diagnosed chronic pancreatitis or autoimmune pancreatitis who can give informed consent, are not pregnant or lactating, have not had recent digestive surgery, and have avoided antibiotics, immunosuppressants, and daily probiotics for at least 30 days.
Not a fit: People who recently used antibiotics or immunosuppressants, have other active gastrointestinal diseases, are pregnant or lactating, have malignancy, or have had prior digestive surgery are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this could identify oral bacterial signatures that help with earlier diagnosis or risk stratification for pancreatic disease and guide future prevention or monitoring strategies.
How similar studies have performed: Prior studies have detected oral bacteria in pancreatic tissue and linked microbiota changes to pancreatic disease, but most work has focused on gut microbiota; studies directly profiling oral microbiota in pancreatitis are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * A dated and signed informed consent form cooperate to complete sample collection Exclusion Criteria: * Previous digestive system surgery; During pregnancy or lactation; Complicated with infectious diseases, malignant tumors or other digestive system diseases (such as inflammatory bowel disease, irritable bowel syndrome, abdominal diseases, gastroesophageal reflux, etc.); Antibiotics and immunosuppressive drugs were used within 30 days before sampling; Those who take probiotics daily.
Where this trial is running
Shanghai, Shanghai, China
- Department of Gastroenterolog, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai, China, 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.
Conditions: Oral Microbiota, Pancreatitis, Pancreatic Cancer