Characteristics of Intestinal Microbiome Following Pancreatic Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRoyal Prince Alfred Hospital, Sydney, Australia
About this trial
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)
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Post-surgical patients are adults (aged ≥ 18 years) who have undergone a pancreatoduodenectomy (Whipple's) surgery for curative between the time period of April 2018 - December 2023, and received post-operative clinical management at Royal Prince Alfred Hospital. Healthy adults (matched controls) will be matched by age, sex, body mass index and smoking status.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
20 Participants
are grouped into 2 trial groupsGroup A: Post-surgical patients
Group B: Matched controls
Trial outcomes
Primary outcomes
1
Comparison of microbiota profile between post-surgical participants and healthy controls.
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.
Time frame
During data collection, 3 daysSecondary outcomes
1
Compliance with 3-day food dairies
Compliance with 3-day food dairies (completion rate of food diaries)
Time frame
From enrollment to the collection of data from participants, 3 days2
Pre-paid return rates
Pre-paid return rates (proportion (number) of envelopes returned)
Time frame
From enrollment to the collection of data from participants, 3 days3
Ease of matching
Ease of matching (ability to match surgical patients to controls based on age, gender, body mass index, smoking status)
Time frame
Enrollment period, up to 12 months4
Shannon diversity index
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)
Time frame
During data collection period, 3 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov