Actively Recruiting
Characteristics of Intestinal Microbiome Following Pancreatic Surgery
Led by Royal Prince Alfred Hospital, Sydney, Australia · Updated on 2025-07-24
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this observational study is to learn about intestinal microbiome structure and function in individuals who have undergone a pancreatoduodenectomy and compare to healthy matched controls. The primary objectives of the study are: 1. To explore and describe any differences in the gut microbiota especially Shannon diversity index 2. To conduct functional profiling by exploring and describing any differences in functional metabolites produced in the gut in people having had pancreatoduodenectomy greater than 6 months ago compared to healthy matched controls. Participants will be asked to complete the following: * Three-day food, bowel and medication diary (see Protocol appendix 5) * Gastrointestinal Symptom Rating Scale (see Protocol appendix 6) * Quality of life questionnaire (see Protocol appendix 7) * Stool sample test using Microba Insight TradeMark (a small swab is taken from soiled toilet paper, sealed in a room-temperature storage capsule and mailed to the testing laboratory)
CONDITIONS
Official 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 between April 2018 and December 2023 for curative intent and received post-operative care 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 difficulties
- Have active or recurring pancreatic cancer or had surgery for non-curative intent
- Have 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 affect gut symptoms or microbiome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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