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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06319755
Other study ID # X23-0230
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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