2025-02-18
2026-02-28
2026-02-28
360
NCT07015580
Ruijin Hospital
Ruijin Hospital
OBSERVATIONAL
The Characteristics of Oral Microbiota in Chronic Pancreatitis and Autoimmune Pancreatitis
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.
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These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates | Results Reporting Dates | Study Record Updates |
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2025-06-04 | N/A | 2025-06-04 |
2025-06-04 | N/A | 2025-06-11 |
2025-06-11 | N/A | 2025-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
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Allocation:
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Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
Participant Group/Arm | Intervention/Treatment |
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: 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
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: 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 pati | OTHER: 16S rRNA sequencing
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: 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
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Primary Outcome Measures | Measure Description | Time Frame |
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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 Outcome Measures | Measure Description | Time Frame |
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Differences in oral microbiota profiles between chronic pancreatitis and autoimmune pancreatitis, pancreatic cancer healthy controll. | 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. | From enrollment to the end at 2 weeks |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
1
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.