Oral MicrobiotaNCT07015580
The Characteristics of Oral Microbiota in Chronic Pancreatitis and Autoimmune Pancreatitis
An observational study of Oral Microbiota and Pancreatitis, run by Ruijin Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Microbiota, Pancreatitis, Pancreatic Cancer
- What is being tested?
- 16S rRNA sequencing
- Type of treatment
- Pill or oral medicine
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 18 Feb 2025to 28 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients diagnosed with chronic pancreatitis or autoimmune pancreatitis or pancreatic cancer
Who may be able to join
- A dated and signed informed consent form cooperate to complete sample collection
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Gastroenterolog, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai, China
Zou Duowu, MD, 86+13901617608, zdw_pi@126.com
About this study
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
- Being tested
- 16S rRNA sequencing
- Medical subject headings
- Pancreatitis, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
16S rRNA sequencingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: 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. Receives: Other: 16S rRNA sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
characteristic of oral microbiota in patients with chronic pancreatitis
Species composition of oral microbiota in pantients chronic pancreatitis
Measured: 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.
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.
Measured: From enrollment to the end at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start18 Feb 2025
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MicrobiotaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZOU DUOWU, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07015580
- Sponsor's protocol ID
- RuijinH202538
- Status last verified
- Jan 2025
- First submitted
- 4 Jun 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Characteristics of Oral Microbiota in Chronic Pancreatitis and Autoimmune Pancreatitis
- ClinicalTrials.gov ID
- NCT07015580
- Acronym / sponsor ID
- RuijinH202538
- Conditions
- Oral Microbiota, Pancreatitis, Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| chronic pancreatitis | – | Other: 16S rRNA sequencingClinical 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 | – | Other: 16S rRNA sequencingClinical 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 | – | Other: 16S rRNA sequencingGender, 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 |
| healthy control | – | Other: 16S rRNA sequencingGender, 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with chronic pancreatitis or autoimmune pancreatitis or pancreatic cancer
Key inclusion criteria (1 listed)
- A dated and signed informed consent form cooperate to complete sample collection
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 16S rRNA sequencingClinical 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 | autoimmune pancreatitis, chronic pancreatitis, healthy control, pancreatic cancer |
Primary outcome
characteristic of oral microbiota in patients with chronic pancreatitis
Time frame: From enrollment to the end at 2 weeks
Species composition of oral microbiota in pantients chronic pancreatitis
1 secondary outcome
Differences in oral microbiota profiles between chronic pancreatitis and autoimmune pancreatitis, pancreatic cancer healthy controll.
Time frame: From enrollment to the end at 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Department of Gastroenterolog, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Microbiota and Pancreatitis, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
characteristic of oral microbiota in patients with chronic pancreatitis (time frame: From enrollment to the end at 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.