Microbiota, Pancreatic Cancer, Pancreatoduodenectomy
Conditions
Keywords
matched case control study
Brief summary
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)
Interventions
None listed
Sponsors
Royal Prince Alfred Hospital, Sydney, Australia
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of microbiota profile between post-surgical participants and healthy controls. | During data collection, 3 days | Stool samples will be analysed to compare the Shannon diversity index (calculated by taking the number of each microbial species, the proportion each species is of the total number of individuals, summed by the proportion times the natural log of the proportion for each species) between participant groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pre-paid return rates | From enrollment to the collection of data from participants, 3 days | Pre-paid return rates (proportion (number) of envelopes returned) |
| Ease of matching | Enrollment period, up to 12 months | Ease of matching (ability to match surgical patients to controls based on age, gender, body mass index, smoking status) |
| Compliance with 3-day food dairies | From enrollment to the collection of data from participants, 3 days | Compliance with 3-day food dairies (completion rate of food diaries) |
| Gastrointestinal symptoms | During data collection period, 3 days | Gastrointestinal symptoms (total number of bowel motions) |
| Protein:fibre ratio of diet | During data collection period, 3 days | Protein:fibre ratio of diet (average grams of protein consumed divided by grams of fibre consumed) |
| Shannon diversity index | During data collection period, 3 days | Shannon diversity index (calculated by taking the number of each microbial species, the proportion each species is of the total number of individuals, summed by the proportion times the natural log of the proportion for each species) |
Countries
Australia
Contacts
Primary ContactDale Palmer
Outcome results
None listed