Characteristics of Intestinal Microbiome Following Pancreatic Surgery
Launched by ROYAL PRINCE ALFRED HOSPITAL, SYDNEY, AUSTRALIA · Mar 12, 2024
Trial Information
Current as of July 21, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at the gut bacteria, known as the intestinal microbiome, in people who have had a specific type of surgery for pancreatic cancer called pancreatoduodenectomy (often referred to as Whipple's surgery). The researchers want to understand how this surgery affects the microbiome and how it differs from healthy individuals who haven't had the surgery. They will compare the gut health and function between these two groups to see if there are any significant changes.
To participate in this study, you need to be an adult (18 years or older) who has had the pancreatoduodenectomy surgery between April 2018 and December 2023, and you must be receiving follow-up care at Royal Prince Alfred Hospital. Healthy adults of the same age and gender will also be included as a comparison group. If you join, you'll keep a three-day diary of your food, bowel movements, and medications, complete some questionnaires about your gastrointestinal symptoms and quality of life, and provide a stool sample using a simple swab method. It's important to note that participants who are currently pregnant, have ongoing gastrointestinal conditions, or are taking certain medications may not be eligible for this study.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Adults (aged equal to or greater than 18 years) having had pancreatoduodenectomy (Whipple's) surgery between April 2018 - December 2023 for curative intent and received post-operative clinical management at Royal Prince Alfred Hospital, (post-surgical participants), and
- • Healthy adults matched by age, sex, body mass index and smoking status
- Exclusion Criteria:
- • Aged less than 18 years
- • Are unable to complete the questionnaires or testing due to language or cognitive limitations
- • Have active or recurring pancreatic cancer, or where the surgery was for non-curative intent
- • Have other gastrointestinal conditions that could affect gut symptoms or microbiome such as Inflammatory Bowel disease, Irritable Bowel Syndrome Coeliac disease, or are currently pregnant or breastfeeding
- • Are currently taking medications or diet that can affect gut symptoms or microbiome
About Royal Prince Alfred Hospital, Sydney, Australia
Royal Prince Alfred Hospital (RPAH) in Sydney, Australia, is a leading tertiary healthcare facility renowned for its commitment to high-quality patient care, innovative research, and medical education. As a prominent clinical trial sponsor, RPAH engages in cutting-edge studies across various medical disciplines, aiming to advance treatment options and improve patient outcomes. The hospital's multidisciplinary team of experienced clinicians and researchers collaborates with national and international partners to conduct rigorous trials that adhere to the highest ethical and scientific standards, fostering a culture of excellence in clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported