RecruitingNCT06319755

Characteristics of Intestinal Microbiome Following Pancreatic Surgery

Characteristics of Intestinal Microbiome Following Pancreatic Surgery - a Prospective Case Controlled Exploratory Study

Sponsor

Royal Prince Alfred Hospital, Sydney, Australia

Enrollment

20 participants

Start Date

Aug 1, 2024

Study Type

OBSERVATIONAL

Conditions

Pancreatic Cancer Microbiota Pancreatoduodenectomy

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)

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at how the gut microbiome (the community of bacteria living in the intestines) changes in people who have had a Whipple surgery (a major operation to remove part of the pancreas) for pancreatic cancer. Researchers compare gut bacteria, digestion, and quality of life in post-surgery patients versus healthy matched volunteers. **You may be eligible if...** - You are 18 years or older - You had a Whipple surgery (pancreatoduodenectomy) for curative intent between April 2018 and December 2023 at Royal Prince Alfred Hospital - OR you are a healthy adult matched in age, sex, BMI, and smoking status to a surgical participant **You may NOT be eligible if...** - You are under 18 - You have active or recurrent pancreatic cancer, or surgery was performed for a non-curative purpose - You have other gut conditions like Crohn's disease, IBS, or celiac disease - You are currently pregnant or breastfeeding - Language or cognitive difficulties prevent you from completing the questionnaires Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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