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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
Scientific title
Ileal Pouch Microbiome Study: defining a pre-operative microbiological signature that predisposes to anastomotic leak
Secondary ID [1] 300749 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 316596 0
Condition category
Condition code
Surgery 314821 314821 0 0
Other surgery
Oral and Gastrointestinal 314822 314822 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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
Intervention code [1] 317080 0
Early Detection / Screening
Comparator / control treatment
Microbiome sequence profiles pre-ileal pouch surgery in patients that do not experience an anastomotic leak following surgery
Control group
Active

Outcomes
Primary outcome [1] 323176 0
Microbiome profiles in stool.
Microbiome profiles in stool will be assessed by 16S rRNA and metagenomic sequencing of microbial genera and species.
Timepoint [1] 323176 0
Day of surgery (Day 0)
Primary outcome [2] 323177 0
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
Timepoint [2] 323177 0
Day of surgery (Day 0)
Primary outcome [3] 323310 0
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
Timepoint [3] 323310 0
Day 0 (day of surgery)
Secondary outcome [1] 381087 0
Pouchitis
Pouchitis will be assessed by clinical examination and pouchoscopy
Timepoint [1] 381087 0
After discharge from hospital post surgery (at regular follow up appointments 6 weeks, 6 months, 12 months, 18 months)
Secondary outcome [2] 381516 0
fistulating perianal disease
Examined by clinical examination and pelvic imaging (CT scan)
Timepoint [2] 381516 0
6 weeks post surgery and at each postsurgical follow up appointment (6 months, 12 months, 18 months)
Secondary outcome [3] 381517 0
Anastomotic leak following surgery
Anastomotic leak will be assessed by clinical examination together with blood tests and CT scan
Timepoint [3] 381517 0
Day 1, Day 2, Day 3, Day 4 and Day 5, post surgery during hospital admission

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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age less than 18 years
Inability to give consent
Pregnant

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/04/2020
Actual
Date of last participant enrolment
Anticipated
31/12/2021
Actual
Date of last data collection
Anticipated
30/12/2023
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 16097 0
Holy Spirit Northside - Chermside
Recruitment hospital [2] 16098 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 29610 0
4032 - Chermside
Recruitment postcode(s) [2] 29611 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 305205 0
Charities/Societies/Foundations
Name [1] 305205 0
Royal Brisbane Women's Hospital Foundation
Country [1] 305205 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane Womens Hospital (RBWH)
Address
Butterfield Street
HERSTON QLD 4029
Country
Australia
Secondary sponsor category [1] 305564 0
None
Name [1] 305564 0
Address [1] 305564 0
Country [1] 305564 0
Other collaborator category [1] 281231 0
Individual
Name [1] 281231 0
Graham Radford-Smith
Address [1] 281231 0
QIMR Berghofer Medical Research Institute (QIMRB)
Gut Health Laboratory
300 Herston Rd
Herston QLD 4029
Country [1] 281231 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305557 0
St Vincent's Health and Aged Care HREC [EC00324]
Ethics committee address [1] 305557 0
Ethics committee country [1] 305557 0
Australia
Date submitted for ethics approval [1] 305557 0
20/01/2020
Approval date [1] 305557 0
21/02/2020
Ethics approval number [1] 305557 0
HREC 19/33

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100770 0
A/Prof David Clark
Address 100770 0

St Vincent’s Private Hospital Northside
627 Rode Road
Chermside Queensland 4032
AUSTRALIA
Country 100770 0
Australia
Phone 100770 0
+61 733502088
Fax 100770 0
+61 7 3350 2333
Email 100770 0
david@davidclark.net.au
Contact person for public queries
Name 100771 0
David Clark
Address 100771 0
St Vincent’s Private Hospital Northside
627 Rode Road
Chermside Queensland 4032
AUSTRALIA
Country 100771 0
Australia
Phone 100771 0
+61 733502088
Fax 100771 0
Email 100771 0
david@davidclark.net.au
Contact person for scientific queries
Name 100772 0
David Clark
Address 100772 0
St Vincent’s Private Hospital Northside
627 Rode Road
Chermside Queensland 4032
AUSTRALIA
Country 100772 0
Australia
Phone 100772 0
+61 733502088
Fax 100772 0
Email 100772 0
david@davidclark.net.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7294Study protocol  aleksandra.edmundson@uq.edu.au



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.