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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Australia
Department of Nutrition and Dietetics, Royal Prince Alfred Hospital
RECRUITING
Camperdown
Contact Information
Primary
Dale Palmer
dale.palmer@health.nsw.gov.au
61295158053
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2025-08
Participants
Target number of participants: 20
Treatments
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.
Sponsors
Leads: Royal Prince Alfred Hospital, Sydney, Australia

This content was sourced from clinicaltrials.gov