Characteristics of Intestinal Microbiome Following Pancreatic Surgery

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:

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)

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Cancer; Microbiota; Pancreatoduodenectomy

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Dale Palmer; Phone Number: 61295158053; Email: dale.palmer@health.nsw.gov.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During data collection, 3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance with 3-day food dairies	Compliance with 3-day food dairies (completion rate of food diaries)	From enrollment to the collection of data from participants, 3 days
Pre-paid return rates	Pre-paid return rates (proportion (number) of envelopes returned)	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)	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)	During data collection period, 3 days
Gastrointestinal symptoms	Gastrointestinal symptoms (total number of bowel motions)	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)	During data collection period, 3 days

Collaborators and Investigators

• Sponsor: Royal Prince Alfred Hospital, Sydney, Australia

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: March 6, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: matched case control study
• Other Study ID Numbers: X23-0230

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No