Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06319755
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-03-06
Brief Title:
Characteristics of Intestinal Microbiome Following Pancreatic Surgery
Sponsor:
Royal Prince Alfred Hospital Sydney Australia
Organization:
Royal Prince Alfred Hospital Sydney Australia
Study Overview
Official Title:
Characteristics of Intestinal Microbiome Following Pancreatic Surgery - a Prospective Case Controlled Exploratory Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None