Gut microbiome after Whipple (pancreatoduodenectomy) surgery
Characteristics of Intestinal Microbiome Following Pancreatic Surgery - a Prospective Case Controlled Exploratory Study
We will see if the gut microbiome and the metabolites it produces differ in adults who had Whipple (pancreatoduodenectomy) surgery at least six months ago compared with healthy, matched adults.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Royal Prince Alfred Hospital, Sydney, Australia Academic / other |
| Locations | 1 site (Camperdown, New South Wales) |
| Trial ID | NCT06319755 on ClinicalTrials.gov |
What this trial studies
This observational matched case-control project compares adults who had pancreatoduodenectomy (Whipple) for curative intent between April 2018 and December 2023 with healthy controls matched by age, sex, BMI and smoking status. Participants complete a three-day food, bowel and medication diary, symptom and quality-of-life questionnaires, and provide a stool swab sample returned via a room-temperature Microba Insight kit for sequencing and metabolite profiling. The primary analysis will compare gut community diversity (including Shannon index) and functional metabolite profiles between groups. Participants with active cancer, other GI diseases, or current medications/diets known to affect the microbiome are excluded to reduce confounding.
Who should consider this trial
Good fit: Adults aged 18 or older who had pancreatoduodenectomy (Whipple) for curative intent between April 2018 and December 2023 and received post-operative management at Royal Prince Alfred Hospital, plus healthy adults matched by age, sex, BMI and smoking status.
Not a fit: People with active or recurrent pancreatic cancer, surgery done for non-curative intent, other gastrointestinal conditions (e.g., IBD, IBS, coeliac), current pregnancy or breastfeeding, or those taking medications or on diets that affect the microbiome are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the work could identify specific microbiome patterns or metabolites linked to recovery after Whipple surgery and point to targets for future treatments to improve gut health and symptoms.
How similar studies have performed: Previous research has documented microbiome shifts after major gastrointestinal surgery, but detailed matched case-control analyses with combined diversity and functional metabolite profiling after Whipple surgery remain limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Camperdown, New South Wales
- Department of Nutrition and Dietetics, Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia (Recruiting)
Study contacts
- Study coordinator: Dale Palmer
- Email: dale.palmer@health.nsw.gov.au
- Phone: 61295158053
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.