The Characteristics of Oral Microbiota in Chronic Pancreatitis and Autoimmune Pancreatitis

NCT ID: NCT07015580

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 360 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-18
• Study Completion Date: 2026-02-28

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

16S rRNA sequencing

Intervention Type: 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

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.

16S rRNA sequencing

Intervention Type: 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.

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

16S rRNA sequencing

Intervention Type: 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.

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.

16S rRNA sequencing

Intervention Type: 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.

Interventions

16S rRNA sequencing

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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

ZOU DUOWU

Director of Gastroenterology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Shanghai, Shanghai, China, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Zou Duowu, MD

Role: primary

zdw_pi@126.com

86+13901617608

Other Identifiers

RuijinH202538

Identifier Type: -

Identifier Source: org_study_id