Characteristics of Intestinal Microbiome Following Pancreatic Surgery

NCT06319755 | Recruiting

• 1 other identifier: X23-0230
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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:

• 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)

Conditions

Pancreatic Cancer; Microbiota; Pancreatoduodenectomy

Keywords

matched case control study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Compliance with 3-day food dairies

  From enrollment to the collection of data from participants, 3 days

• Pre-paid return rates

  From enrollment to the collection of data from participants, 3 days

• Ease of matching

  Enrollment period, up to 12 months

• Shannon diversity index

  During data collection period, 3 days

• Gastrointestinal symptoms

  During data collection period, 3 days

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Prince Alfred Hospital, Sydney, Australia: lead

Study Sites (1)

Department of Nutrition and Dietetics, Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool samples

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Dale Palmer

CONTACT

61295158053; dale.palmer@health.nsw.gov.au

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Dietitian

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 20, 2024
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: July 24, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)