Pancreatic CancerNCT06319755
Characteristics of Intestinal Microbiome Following Pancreatic Surgery
An observational study of Pancreatic Cancer and Microbiota, run by Royal Prince Alfred Hospital, Sydney, Australia at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer, Microbiota, Pancreatoduodenectomy
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Aug 2024to Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Department of Nutrition and Dietetics, Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Dale Palmer, +610295158053, dale.palmer@health.nsw.gov.au
About this study
Official title: Characteristics of Intestinal Microbiome Following Pancreatic Surgery - a Prospective Case Controlled Exploratory Study
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:
Read more
- To explore and describe any differences in the gut microbiota especially Shannon diversity index
- 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
- Pancreatic Cancer, Microbiota, Pancreatoduodenectomy
- Keywords
- matched case control study
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Post-surgical patients | Adults having had pancreatoduodenectomy (Whipple's) surgery for curative intent. | |
| Matched controls | Participants matched to each post-surgical participant by age, sex, body mass index (BMI), smoking status. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During data collection, 3 days
Secondary outcomes (6)
Compliance with 3-day food dairies
Compliance with 3-day food dairies (completion rate of food diaries)
Measured: From enrollment to the collection of data from participants, 3 days
Pre-paid return rates
Pre-paid return rates (proportion (number) of envelopes returned)
Measured: From enrollment to the collection of data from participants, 3 days
Ease of matching
Ease of matching (ability to match surgical patients to controls based on age, gender, body mass index, smoking status)
Measured: Enrollment period, up to 12 months
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)
Measured: During data collection period, 3 days
Gastrointestinal symptoms
Gastrointestinal symptoms (total number of bowel motions)
Measured: During data collection period, 3 days
Protein:fibre ratio of diet
Protein:fibre ratio of diet (average grams of protein consumed divided by grams of fibre consumed)
Measured: During data collection period, 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start1 Aug 2024
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Prince Alfred Hospital, Sydney, Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dale Palmer, Royal Prince Alfred Hospital, Sydney, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319755
- Sponsor's protocol ID
- X23-0230
- Status last verified
- Jul 2024
- First submitted
- 6 Mar 2024
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Intestinal Microbiome Following Pancreatic Surgery - a Prospective Case Controlled Exploratory Study
- ClinicalTrials.gov ID
- NCT06319755
- Acronym / sponsor ID
- X23-0230
- Conditions
- Pancreatic Cancer, Microbiota, Pancreatoduodenectomy
- Keywords
- matched case control study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Royal Prince Alfred Hospital, Sydney, AustraliaUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To explore and describe any differences in the gut microbiota especially Shannon diversity index
- 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)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-surgical patients | – | –Adults having had pancreatoduodenectomy (Whipple's) surgery for curative intent. |
| Matched controls | – | –Participants matched to each post-surgical participant by age, sex, body mass index (BMI), smoking status. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of microbiota profile between post-surgical participants and healthy controls.
Time frame: 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.
6 secondary outcomes
Compliance with 3-day food dairies
Time frame: From enrollment to the collection of data from participants, 3 days
Pre-paid return rates
Time frame: From enrollment to the collection of data from participants, 3 days
Ease of matching
Time frame: Enrollment period, up to 12 months
Shannon diversity index
Time frame: During data collection period, 3 days
Gastrointestinal symptoms
Time frame: During data collection period, 3 days
Protein:fibre ratio of diet
Time frame: During data collection period, 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer and Microbiota, run by Royal Prince Alfred Hospital, Sydney, Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dale Palmer (61295158053, dale.palmer@health.nsw.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of microbiota profile between post-surgical participants and healthy controls. (time frame: During data collection, 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.