Actively Recruiting
Characteristics of Intestinal Microbiome Following Pancreatic Surgery - a Prospective Case Controlled Exploratory Study
Led by Royal Prince Alfred Hospital, Sydney, Australia · Updated on 2025-07-24
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This observational study aims to understand the structure and function of the intestinal microbiome in adults who have undergone pancreatoduodenectomy (Whipple's) surgery for curative intent. The study compares these post-surgical participants to healthy adults matched by age, sex, body mass index, and smoking status. Researchers will explore differences in gut microbiota diversity and functional metabolites, focusing especially on the Shannon diversity index. Participants include adults who had the surgery between April 2018 and December 2023 and received follow-up care at Royal Prince Alfred Hospital. The study involves two groups: post-surgical patients and matched healthy controls. There is no drug or treatment intervention; instead, the study collects observational data through diaries, questionnaires, and stool samples. Participants will complete a three-day food, bowel, and medication diary, along with questionnaires on gastrointestinal symptoms and quality of life. They will also provide a stool sample using a specialized swab mailed to the laboratory. Researchers will measure microbiota profiles, symptom ratings, dietary protein-to-fiber ratios, and diary compliance. The study monitors participants during the three-day data collection period, with overall enrollment lasting up to 12 months.
CONDITIONS
Brief Title
Characteristics of Intestinal Microbiome Following Pancreatic Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older who had pancreatoduodenectomy (Whipple's) surgery for curative intent between April 2018 and December 2023
- Post-surgical participants must have received clinical management at Royal Prince Alfred Hospital
- Healthy adults matched by age, sex, body mass index, and smoking status
You will not qualify if you...
- Under 18 years of age
- Unable to complete questionnaires or testing due to language or cognitive limitations
- Active or recurring pancreatic cancer, or surgery was for non-curative intent
- Other gastrointestinal conditions affecting gut symptoms or microbiome such as Inflammatory Bowel Disease, Irritable Bowel Syndrome, Coeliac disease
- Currently pregnant or breastfeeding
- Taking medications or diet that can affect gut symptoms or microbiome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 days
Participants provide data on intestinal microbiome and gastrointestinal symptoms over a 3-day period following pancreatic surgery or matched enrollment.
1 to 2 visits depending on cohort assignment
Trial Site Locations
Total: 1 location
1
Department of Nutrition and Dietetics, Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
Research Team
D
Dale Palmer
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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