Characteristics of Intestinal Microbiome Following Pancreatic Surgery

Last updated: July 21, 2025
Sponsor: Royal Prince Alfred Hospital, Sydney, Australia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pancreatic Cancer

Pancreatitis

Pancreatic Disorders

Treatment

N/A

Clinical Study ID

NCT06319755
X23-0230
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

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 andreceived 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

Exclusion Criteria:

  • Aged less than 18 years

  • Are unable to complete the questionnaires or testing due to language or cognitivelimitations

  • Have active or recurring pancreatic cancer, or where the surgery was fornon-curative intent

  • Have other gastrointestinal conditions that could affect gut symptoms or microbiomesuch as Inflammatory Bowel disease, Irritable Bowel Syndrome Coeliac disease, or arecurrently pregnant or breastfeeding

  • Are currently taking medications or diet that can affect gut symptoms or microbiome

Study Design

Total Participants: 20
Study Start date:
August 01, 2024
Estimated Completion Date:
August 31, 2025

Connect with a study center

  • Department of Nutrition and Dietetics, Royal Prince Alfred Hospital

    Camperdown, New South Wales 2050
    Australia

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.