Fatty PancreasFPM1NCT06938646
Microbiome Characterization in Fatty Pancreas
An observational study of Fatty Pancreas and Microbiome Analysis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
There has been a growing interest in evaluating the role of gut and intra-lesional microbiome in the pathogenesis of various benign and malignant conditions of the GI tract, liver and pancreas. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fatty Pancreas, Microbiome Analysis
- How many people
- 120 participants
- Where
- 1 siteHong Kong
- Study dates
- 20 May 2025to 30 Jun 2027
- How long will I take part?
- 6 Months
- 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 who underwent MRI-PDFF for pancreatic fat fraction and liver fat fraction measurements between 1/2022 and 11/2024 for evaluation of FP and fatty liver in GI and hepatology clinics of the Prince of Wales Hospital will be screened for eligibility of this study. Each patient with FP will be matched by sex and age (+/- 3 years) with 1 patient without FP (MRI-PDFF pancreatic fat fraction < 6.2%). Patients with significant alcohol consumption, defined as alcohol intake of over 20g daily (140g weekly) for men and 10g daily (70g weekly) for women will be excluded.
Who may be able to join
- Age 18 or older
- Patients with FP, defined by MRI-PDFF pancreatic fat fraction > 6.2%
- Patients who are able to provide written informed consent to participate in the study.
Who cannot join
- Unable to provide written informed consent
- Recent use of antibiotic, prebiotic, probiotic and symbiotic
- Patients with significant alcohol consumption, defined as alcohol intake of over 20 g daily (140 g weekly) for men and 10 g daily (70 g weekly) for women
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Prince of Wales Hospital, The Chinese University of Hong Kong
Shatin, New Territories
About this study
Official title: Microbiome Characterization in Patients With Fatty Pancreas: a Pilot Cohort Study
There has been a growing interest in evaluating the role of gut and intra-lesional microbiome in the pathogenesis of various benign and malignant conditions of the GI tract, liver and pancreas. In addition, the feasibility of using microbiome signature as non-invasive biomarker for benign and malignant disease conditions of the GI tract has also been studied. While research on the impact of microbiome and genomics has been conducted in some pancreatic disorders such as acute pancreatitis, pre-malignant mucinous pancreatic cystic neoplasms (eg, IPMN) and pancreatic cancer, very little data is available regarding the microbiome signature and genomics associated with FP. As such, it would be clinically important to conduct a pilot study to investigate the microbiome and genomics associated in patients with or without FP defined by MRI-PDFF pancreatic fat fraction measurement.
Read the detailed description
Fatty pancreas (FP) is a pathological metabolic condition characterized by excessive intra-pancreatic fat deposition (IPFD). FP is an increasingly recognized metabolic condition with a prevalence of 16% to 35% in Asian populations. While ultrasound, computed tomography (CT) and magnetic resonance imaging (MRI) have been used for fat quantitation in organs, MRI is best suited for this purpose since its signal is dependent on fat content. Quantitative proton density fat fraction measurement by MRI (MRI-PDFF) is regarded as the current gold standard for fat quantification in organs such as liver and pancreas since the fat fraction measurements by MRI are reproducible, accurate and have been validated against histology. In a meta-analysis of 9 studies using MRI for pancreatic fat quantification, the upper limit of normal of pancreatic fat in healthy subjects was 6.2%.
FP has gained clinical attention since FP has been associated with both benign and malignant diseases of the pancreas. For example, recent retrospective studies have suggested an increased risk of pancreatic cancer, intraductal papillary mucinous neoplasms (IPMN) and neoplastic progression of Branch Duct type IPMN (BD-IPMN) in patients with FP defined by computed tomography (CT) attenuation indexes . In another retrospective study of 62 patients using MRI-PDFF for pancreatic fat quantification, high pancreatic fat fraction was associated with high-risk IPMN in surgical specimen. In a community cohort study of 685 adult Chinese volunteers, our team was the first to report on the prevalence of FP (16.1%) in Hong Kong adults using MRI for pancreatic fat quantification in 2014 . In our recently published 10-year prospective follow-up study of the same cohort, FP was independently associated with subsequent diabetes development.
- Conditions
- Fatty Pancreas, Microbiome Analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with fatty pancreas | Patients who underwent MRI-PDFF for pancreatic fat fraction and liver fat fraction measurements between 1/2022 and 11/2024 for evaluation of FP and fatty liver in GI and hepatology clinics of the Prince of Wales Hospital will be screened for eligibility of this study. Each patient with FP will be matched by sex and age (+/- 3 years) with 1 patient without FP (MRI-PDFF pancreatic fat fraction < 6.2%). Patients with significant alcohol consumption, defined as alcohol intake of over 20g daily (140g weekly) for men and 10g daily (70g weekly) for women will be excluded. | |
| Healthy subjects | Healthy subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiome in patients with FP
Characterization of the gut microbiome in patients with FP (defined by MRI-PDFF pancreatic fat fraction > 6.2%) and age-sex matched subjects without FP
Measured: At the time of procedure
Secondary outcomes (2)
Gut microbiome in patients with FP and co-existing fatty liver, patients with FP alone, patients with fatty liver alone, and patients without FP and fatty liver
To evaluate the difference in gut microbiome in patients with FP and co-existing fatty liver (defined by MRI-PDFF intrahepatic fat fraction > 5%), patients with FP alone, patients with fatty liver alone, and patients without FP and fatty liver
Measured: At the time of procedure
Correlation of gut microbiome in the subgroup of patients with FP and mucinous pancreatic cystic size and presence of worrisome features
To correlate the gut microbiome in the subgroup of patients with FP and mucinous pancreatic cystic neoplasms (PCN) (eg, IPMN) with PCN size and presence of worrisome features defined by the 2024 Kyoto evidence-based consensus guidelines
Measured: At the time of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start20 May 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty PancreasStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- 120 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raymond Shing Yan Tang, Chinese University of Hong Kong
- Investigators
- Raymond S Tang, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938646
- Sponsor's protocol ID
- 2024.585
- Acronym
- FPM1
- Status last verified
- Oct 2026
- First submitted
- 8 Apr 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiome Characterization in Patients With Fatty Pancreas: a Pilot Cohort Study
- ClinicalTrials.gov ID
- NCT06938646
- Acronym / sponsor ID
- FPM1 / 2024.585
- Conditions
- Fatty Pancreas, Microbiome Analysis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 20 May 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 22 Apr 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 has been a growing interest in evaluating the role of gut and intra-lesional microbiome in the pathogenesis of various benign and malignant conditions of the GI tract, liver and pancreas. In addition, the feasibility of using microbiome signature as non-invasive biomarker for benign and malignant disease conditions of the GI tract has also been studied. While research on the impact of microbiome and genomics has been conducted in some pancreatic disorders such as acute pancreatitis, pre-malignant mucinous pancreatic cystic neoplasms (eg, IPMN) and pancreatic cancer, very little data is available regarding the microbiome signature and genomics associated with FP. As such, it would be clinically important to conduct a pilot study to investigate the microbiome and genomics associated in patients with or without FP defined by MRI-PDFF pancreatic fat fraction measurement.
Detailed description
Fatty pancreas (FP) is a pathological metabolic condition characterized by excessive intra-pancreatic fat deposition (IPFD). FP is an increasingly recognized metabolic condition with a prevalence of 16% to 35% in Asian populations. While ultrasound, computed tomography (CT) and magnetic resonance imaging (MRI) have been used for fat quantitation in organs, MRI is best suited for this purpose since its signal is dependent on fat content. Quantitative proton density fat fraction measurement by MRI (MRI-PDFF) is regarded as the current gold standard for fat quantification in organs such as liver and pancreas since the fat fraction measurements by MRI are reproducible, accurate and have been validated against histology. In a meta-analysis of 9 studies using MRI for pancreatic fat quantification, the upper limit of normal of pancreatic fat in healthy subjects was 6.2%.
FP has gained clinical attention since FP has been associated with both benign and malignant diseases of the pancreas. For example, recent retrospective studies have suggested an increased risk of pancreatic cancer, intraductal papillary mucinous neoplasms (IPMN) and neoplastic progression of Branch Duct type IPMN (BD-IPMN) in patients with FP defined by computed tomography (CT) attenuation indexes . In another retrospective study of 62 patients using MRI-PDFF for pancreatic fat quantification, high pancreatic fat fraction was associated with high-risk IPMN in surgical specimen. In a community cohort study of 685 adult Chinese volunteers, our team was the first to report on the prevalence of FP (16.1%) in Hong Kong adults using MRI for pancreatic fat quantification in 2014 . In our recently published 10-year prospective follow-up study of the same cohort, FP was independently associated with subsequent diabetes development.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with fatty pancreas | – | –Patients who underwent MRI-PDFF for pancreatic fat fraction and liver fat fraction measurements between 1/2022 and 11/2024 for evaluation of FP and fatty liver in GI and hepatology clinics of the Prince of Wales Hospital will be screened for eligibility of this study. Each patient with FP will be matched by sex and age (+/- 3 years) with 1 patient without FP (MRI-PDFF pancreatic fat fraction < 6.2%). Patients with significant alcohol consumption, defined as alcohol intake of over 20g daily (140g weekly) for men and 10g daily (70g weekly) for women will be excluded. |
| Healthy subjects | – | –Healthy subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent MRI-PDFF for pancreatic fat fraction and liver fat fraction measurements between 1/2022 and 11/2024 for evaluation of FP and fatty liver in GI and hepatology clinics of the Prince of Wales Hospital will be screened for eligibility of this study. Each patient with FP will be matched by sex and age (+/- 3 years) with 1 patient without FP (MRI-PDFF pancreatic fat fraction < 6.2%). Patients with significant alcohol consumption, defined as alcohol intake of over 20g daily (140g weekly) for men and 10g daily (70g weekly) for women will be excluded.
Key inclusion criteria (3 listed)
- Age 18 or older
- Patients with FP, defined by MRI-PDFF pancreatic fat fraction > 6.2%
- Patients who are able to provide written informed consent to participate in the study.
Key exclusion criteria (3 listed)
- Unable to provide written informed consent
- Recent use of antibiotic, prebiotic, probiotic and symbiotic
- Patients with significant alcohol consumption, defined as alcohol intake of over 20 g daily (140 g weekly) for men and 10 g daily (70 g weekly) for women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gut microbiome in patients with FP
Time frame: At the time of procedure
Characterization of the gut microbiome in patients with FP (defined by MRI-PDFF pancreatic fat fraction > 6.2%) and age-sex matched subjects without FP
2 secondary outcomes
Gut microbiome in patients with FP and co-existing fatty liver, patients with FP alone, patients with fatty liver alone, and patients without FP and fatty liver
Time frame: At the time of procedure
Correlation of gut microbiome in the subgroup of patients with FP and mucinous pancreatic cystic size and presence of worrisome features
Time frame: At the time of procedure
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 27 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Raymond S Tang, MD principal investigator
Chinese University of Hong Kong
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 Fatty Pancreas and Microbiome Analysis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. 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 Hong Kong. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiome in patients with FP (time frame: At the time of procedure). 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 27 Oct 2026.