The Characteristics of Oral Microbiota in Chronic Pancreatitis and Autoimmune Pancreatitis

NCT07015580 | Recruiting DMC

• 1 other identifier: RuijinH202538
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Microbiota; Pancreatitis; Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• characteristic of oral microbiota in patients with chronic pancreatitis

  Species composition of oral microbiota in pantients chronic pancreatitis

  From enrollment to the end at 2 weeks

Secondary Outcomes (1)

• Differences in oral microbiota profiles between chronic pancreatitis and autoimmune pancreatitis, pancreatic cancer healthy controll.

  From enrollment to the end at 2 weeks

Study Arms (4)

chronic pancreatitis

Clinical data including medical history, clinical symptoms, imaging examination, laboratory examination will be collected. 3-5ml saliva sample of every patients will be collected for 16S rRNA sequencing of oral microbiota.

Other: 16S rRNA sequencing

autoimmune pancreatitis

Clinical data including medical history, clinical symptoms, imaging examination, laboratory examination will be collected. 3-5ml saliva sample of every patients will be collected for 16S rRNA sequencing of oral microbiota.

Other: 16S rRNA sequencing

pancreatic cancer

Gender, age (± 5 years), smoking and drinking are matched with patients with chronic pancreatitis. Clinical data including medical history, clinical symptoms, imaging examination, laboratory examination will be collected. 3-5ml saliva sample of every patients will be collected for 16S rRNA sequencing of oral microbiota. considering sugery or endoscopy may change the oral microbiota, the saliva sample will be collected in pantients with suspected pancreatic cancer. Only pantients with pathologically confirmed pancreatic cancer will be inclueded in final analysis

Other: 16S rRNA sequencing

healthy control

Gender, age (± 5 years), smoking and drinking are matched with patients with chronic pancreatitis. 3-5ml saliva sample of every participant will be collected for 16S rRNA sequencing of oral microbiota.

Other: 16S rRNA sequencing

Interventions

16S rRNA sequencing OTHER

Clinical data including medical history, clinical symptoms, imaging examination, laboratory examination will be collected. 3-5ml saliva sample of every patients will be collected for 16S rRNA sequencing of oral microbiota.

autoimmune pancreatitis; chronic pancreatitis; healthy control; pancreatic cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with chronic pancreatitis or autoimmune pancreatitis or pancreatic cancer

You may qualify if:

• A dated and signed informed consent form cooperate to complete sample collection

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Department of Gastroenterolog, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai, China, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

saliva

MeSH Terms

Conditions

Pancreatitis; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gastroenterology Department

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 11, 2025
• Study Start: February 18, 2025
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: June 11, 2025

Record last verified: 2025-01

Locations

CN (1)