Characteristics of Intestinal Microbiome Following Pancreatic Surgery

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06319755
• Other study ID #: X23-0230
• Status: Not yet recruiting
• Start date: March 2024
• Est. completion date: February 2025

Study information

• Verified date: March 2024
• Source: Royal Prince Alfred Hospital, Sydney, Australia
• Contact: Dale Palmer
• Phone: 61295158053
• Email: dale.palmer[@]health.nsw.gov.au
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: February 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Microbiota
• Pancreatic Cancer
• Pancreatoduodenectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Royal Prince Alfred Hospital, Sydney, Australia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Pre-paid return rates	Pre-paid return rates (proportion (number) of envelopes returned)	From enrollment to the collection of data from participants, 3 days
Secondary	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
Secondary	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
Secondary	Gastrointestinal symptoms	Gastrointestinal symptoms (total number of bowel motions)	During data collection period, 3 days
Secondary	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