Characteristics of Intestinal Microbiome Following Pancreatic Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-08-31

Brief Summary

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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)

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Detailed Description

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Conditions

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Pancreatic Cancer Microbiota Pancreatoduodenectomy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Post-surgical patients

Adults having had pancreatoduodenectomy (Whipple's) surgery for curative intent.

No interventions assigned to this group

Matched controls

Participants matched to each post-surgical participant by age, sex, body mass index (BMI), smoking status.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes