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DEFINITIONS
Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12620000484943
Ethics application status
Approved
Date submitted
9/03/2020
Date registered
17/04/2020
Date last updated
17/04/2020
Date data sharing statement initially provided
17/04/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
Ileal Pouch Microbiome Study: defining a pre-operative microbiological signature that predisposes to anastomotic leak
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Scientific title
Ileal Pouch Microbiome Study: defining a pre-operative microbiological signature that predisposes to anastomotic leak
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Secondary ID [1]
300749
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis
316596
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Condition category
Condition code
Surgery
314821
314821
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0
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Other surgery
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Oral and Gastrointestinal
314822
314822
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0
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Inflammatory bowel disease
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
After written consent is obtained:
- Day of surgery (Day 0): stool sample (0.5 ml) will be collected from ileostomy and tissue biopsy will be collected from the resected ileum and rectum. Samples will be immediately frozen on dry ice and stored at -80oC until microbiome analysis.
- Clinical course observation during admission to establish participants who experienced anastomotic leak and participants who did not compare anastomotic leak
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Intervention code [1]
317080
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Early Detection / Screening
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Comparator / control treatment
Microbiome sequence profiles pre-ileal pouch surgery in patients that do not experience an anastomotic leak following surgery
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Control group
Active
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Outcomes
Primary outcome [1]
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Microbiome profiles in stool.
Microbiome profiles in stool will be assessed by 16S rRNA and metagenomic sequencing of microbial genera and species.
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Assessment method [1]
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Timepoint [1]
323176
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Day of surgery (Day 0)
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Primary outcome [2]
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Microbiome sequence profiles in ileal and rectal tissue
A biopsy will be collected from the surgical specimen of rectum and ileum and stored frozen at -80 degrees Celcius until assessment of microbial genera and species. Microbial profiles will be assessed by 16S rRNA sequencing
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Assessment method [2]
323177
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Timepoint [2]
323177
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Day of surgery (Day 0)
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Primary outcome [3]
323310
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Collagenase levels in stool.
Collagenase functional activity will be measured by Immuno-assasy (ELISA)
Collagenase genomic levels in stool will be measured by metagenomic sequencing
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Assessment method [3]
323310
0
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Timepoint [3]
323310
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Day 0 (day of surgery)
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Secondary outcome [1]
381087
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Pouchitis
Pouchitis will be assessed by clinical examination and pouchoscopy
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Assessment method [1]
381087
0
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Timepoint [1]
381087
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After discharge from hospital post surgery (at regular follow up appointments 6 weeks, 6 months, 12 months, 18 months)
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Secondary outcome [2]
381516
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fistulating perianal disease
Examined by clinical examination and pelvic imaging (CT scan)
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Assessment method [2]
381516
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Timepoint [2]
381516
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6 weeks post surgery and at each postsurgical follow up appointment (6 months, 12 months, 18 months)
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Secondary outcome [3]
381517
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Anastomotic leak following surgery
Anastomotic leak will be assessed by clinical examination together with blood tests and CT scan
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Assessment method [3]
381517
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Timepoint [3]
381517
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Day 1, Day 2, Day 3, Day 4 and Day 5, post surgery during hospital admission
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Eligibility
Key inclusion criteria
Ileal pouch surgery without a covering loop ileostomy
J, W or S pouch configuration
Indication must be Ulcerative Colitis
Must be staged (ie. prior total colectomy and ileostomy)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Age less than 18 years
Inability to give consent
Pregnant
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Study design
Purpose
Screening
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
Microbiological sequence profiles will be analysed by specialised bio-analyst. Sequence profiles will be correlated to post surgical outcomes (anastomotic leak, pouchitis, fistulating perianal disease
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
17/04/2020
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Actual
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Date of last participant enrolment
Anticipated
31/12/2021
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Actual
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Date of last data collection
Anticipated
30/12/2023
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
16097
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Holy Spirit Northside - Chermside
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Recruitment hospital [2]
16098
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Royal Brisbane & Womens Hospital - Herston
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Recruitment postcode(s) [1]
29610
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4032 - Chermside
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Recruitment postcode(s) [2]
29611
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4029 - Herston
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Funding & Sponsors
Funding source category [1]
305205
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Charities/Societies/Foundations
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Name [1]
305205
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Royal Brisbane Women's Hospital Foundation
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Address [1]
305205
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Butterfield Street
HERSTON QLD 4029
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Country [1]
305205
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Australia
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Primary sponsor type
Hospital
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Name
Royal Brisbane Womens Hospital (RBWH)
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Address
Butterfield Street
HERSTON QLD 4029
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Country
Australia
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Secondary sponsor category [1]
305564
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None
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Name [1]
305564
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Address [1]
305564
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Country [1]
305564
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Other collaborator category [1]
281231
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Individual
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Name [1]
281231
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Graham Radford-Smith
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Address [1]
281231
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QIMR Berghofer Medical Research Institute (QIMRB)
Gut Health Laboratory
300 Herston Rd
Herston QLD 4029
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Country [1]
281231
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
305557
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St Vincent's Health and Aged Care HREC [EC00324]
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Ethics committee address [1]
305557
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St Vincent's Private Hospital Northside
627 Rode Rd
Chermside QLD 4032
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Ethics committee country [1]
305557
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Australia
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Date submitted for ethics approval [1]
305557
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20/01/2020
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Approval date [1]
305557
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21/02/2020
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Ethics approval number [1]
305557
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HREC 19/33
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Summary
Brief summary
Anastomotic leakage (AL) is amongst the most significant complications of intestinal surgery and results in increased morbidity and mortality. Recent research has shown that certain species of E. coli and Pseudomonas have been associated with AL in colorectal anastomoses. These organisms produce collagenases and metalloproteinases that can break down a newly constructed and healing anastomosis. Much research has also gone into defining bacterial populations that are associated with pouchitis. Our project aims to describe the microbiological communities in the terminal ileum and rectum that will contribute to the ultimate ileal pouch microbiome. The future application of this information is to allow intervention for manipulation of the microbiome to more favourable microbial profiles prior to surgery, and thus reduce the leak rate and perhaps, in the long term, protect against the development of pouchitis and perianal disease.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof David Clark
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Address
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St Vincent’s Private Hospital Northside
627 Rode Road
Chermside Queensland 4032
AUSTRALIA
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Country
100770
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Australia
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Phone
100770
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+61 733502088
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Fax
100770
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+61 7 3350 2333
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Email
100770
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[email protected]
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Contact person for public queries
Name
100771
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A/Prof David Clark
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Address
100771
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St Vincent’s Private Hospital Northside
627 Rode Road
Chermside Queensland 4032
AUSTRALIA
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Country
100771
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Australia
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Phone
100771
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+61 733502088
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Fax
100771
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Email
100771
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[email protected]
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Contact person for scientific queries
Name
100772
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A/Prof David Clark
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Address
100772
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St Vincent’s Private Hospital Northside
627 Rode Road
Chermside Queensland 4032
AUSTRALIA
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Country
100772
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Australia
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Phone
100772
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+61 733502088
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Fax
100772
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Email
100772
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
HREC approval restricts the use and analysis of identifiable data.
All participant records will be deidentified and only summary statistics shared and published
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
7294
Study protocol
[email protected]
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF