Microbiome Characterization in Fatty Pancreas

NCT06938646 | Active Not Recruiting

• 1 other identifier: 2024.585
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Fatty Pancreas; Microbiome Analysis

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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

  At the time of procedure

Study Arms (2)

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

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 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital, The Chinese University of Hong Kong

Shatin, New Territories, Hong Kong

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool sample One bottle of stool specimen will be collected in sterile container. The collected stool specimen will be placed on ice and promptly transferred to a -80°C refrigerator for cryopreservation. Blood sample 10ml of blood will be collected in ethylenediaminetetraacetic acid (EDTA) tubes. The collected blood sample will be promptly transferred to a -80°C refrigerator for cryopreservation.

Study Officials

• Raymond S Tang, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 22, 2025
• Study Start: May 20, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)