Characteristics of Intestinal Microbiome Following Pancreatic Surgery
- Conditions
- Pancreatic CancerMicrobiotaPancreatoduodenectomy
- Registration Number
- NCT06319755
- Lead Sponsor
- Royal Prince Alfred Hospital, Sydney, Australia
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)