The Characteristics of Oral Microbiota in Chronic Pancreatitis and Autoimmune Pancreatitis

Recruiting

• Conditions: Oral Microbiota; Pancreatitis; Pancreatic Cancer

• Registration Number: NCT07015580
• Lead Sponsor: Ruijin Hospital

Brief Summary

There are more than 700 different bacteria colonized in human oral cavity, which are collectively referred to as oral microbiota. Emerging evidence suggests that oral microbiota plays a series of important roles in human health, such as immune response, carcinogen metabolism and nutrient digestion. The changes of oral microbiota composition are closely related to the occurrence and development of pancreatic diseases. Previous studies have found that there are dense bacterial biofilms in the pancreatic duct of patients with calcified pancreatitis, including oral bacterial types. However, most studies only focused on the changes of gut microbiota in patients with chronic pancreatitis, and there were lack of research and description on the changes of oral microbiota in patients with chronic pancreatitis. In this study, we will extract and sequence bacterie's full-length 16S rRNA to describe the characteristics of oral microbiota in patients with chronic pancreatitis, confirming that there are changes in oral microbiota in patients with chronic pancreatitis, and compare the differences of oral microbiota in patients with chronic pancreatitis, pancreatic cancer and autoimmune pancreatitis.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-02-18
• Study First Submitted: 2025-06-04
• Study First Submitted QC: 2025-06-04
• Last Update Submitted: 2025-06-04
• Study First Posted: 2025-06-11
• Last Update Posted: 2025-06-11
• Primary Completion: 2026-02-28
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
characteristic of oral microbiota in patients with chronic pancreatitis	From enrollment to the end at 2 weeks	Species composition of oral microbiota in pantients chronic pancreatitis

Secondary Outcome Measures

Name	Time	Method
Differences in oral microbiota profiles between chronic pancreatitis and autoimmune pancreatitis, pancreatic cancer healthy controll.	From enrollment to the end at 2 weeks	compare the alpha diversity and beta diversity of different groups. Alpha diversity is an index used to reflect the richness and evenness within a sample.Beta diversity is an indicator of species richness and evenness among samples.

Trial Locations

Locations (1)

Department of Gastroenterolog, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China, China