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Trial registered on ANZCTR


Registration number
ACTRN12612000918820
Ethics application status
Not yet submitted
Date submitted
3/05/2012
Date registered
28/08/2012
Date last updated
28/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Hypoxic Regulation of Integrin Beta1 During Mucosal Wound
Healing
Scientific title
Hypoxic Regulation of Integrin Beta1 During Mucosal Wound
Healing
(Crohn’s Disease Study)
Secondary ID [1] 281110 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 287270 0
Condition category
Condition code
Oral and Gastrointestinal 287595 287595 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Samples will be collected from current Inflammatory Bowel Disease (IBD) patients undergoing follow-up/routine endoscopy.

The Gastroenterologist will collect up to 12 small biopsy samples from the bowel during your colonoscopy; of the 12 small samples 5 will be used as standard clinical care the other 7 samples will be frozen and used as part of our research and stored at The University of Newcastle School of Biomedical Sciences and Pharmacy for analysis. The size of the biopsy is small, ranging in size between 2 – 4mm each. Biopsies will be taken from the ileum, ascending colon, descending colon and biopsies from any inflamed areas and non-inflamed areas of the colon.

Thus the sample collection will not involve any additional processes to what the participant will already being undergoing.

Participants will be recruited during procedures and will not be contacted post care.
Intervention code [1] 284792 0
Early detection / Screening
Comparator / control treatment
Control biopsies will be obtained from cancer or lower GI bleeding colonoscopy screenings which are normal with no
history of IBD or IBS that are ongoing during the course of the trial (2012-2015)
Control group
Active

Outcomes
Primary outcome [1] 287855 0
Identification of major mechanisms of mucosal wound healing in active Crohn's inflammation
Timepoint [1] 287855 0
During active inflammation and during remission
Secondary outcome [1] 298943 0
Possible proof of principle for therapeutic strategy to promote wound healing during active inflammation
Timepoint [1] 298943 0
N/A

Eligibility
Key inclusion criteria
Must be non smokers. With diagnosed Crohn's disease and either
CDAI>150

Or previously had CDAI>150 and now below 150
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Must be non smokers with no history of IBD or IBS.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/02/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285892 0
Government body
Name [1] 285892 0
NHMRC
Country [1] 285892 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive,
Callaghan
2308 NSW
Country
Australia
Secondary sponsor category [1] 284715 0
Hospital
Name [1] 284715 0
Hunter Medical Research Institute - John Hunter Hospital
Address [1] 284715 0
John Hunter Hospital
Lookout Road,
New Lambton Heights
2310 NSW
Country [1] 284715 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287921 0
Hunter New England Human Research Ethics Committee (EC00403)
Ethics committee address [1] 287921 0
Hunter New England Health
Locked Bag 1
NEW LAMBTON NSW 2305
Ethics committee country [1] 287921 0
Australia
Date submitted for ethics approval [1] 287921 0
03/05/2012
Approval date [1] 287921 0
Ethics approval number [1] 287921 0
12/04/18/3.01

Summary
Brief summary
One major problem for those afflicted with inflammatory bowel disease (IBD) is the breakdown of the gut wall lining due to inflammation. This breakdown is best described as an open wound allowing bacteria and toxic substances to enter the body through the gut which prolongs and worsens the existing inflammation.
In severe IBD, these wounds may prevent immediate application of certain treatments and require steroids to permit wound healing. This route of therapy often comes with many unwanted side effects for the patient. There is currently very little known about how wound healing is initiated or how it progresses in the gut. Understanding of how the wound healing process is regulated may allow us to improve the treatment of IBD wounding and allow the design of new therapies to control the disease. This project examines the roles and interactions of HIF, a protein that regulates a cells response to lack of oxygen, and of a cell membrane linker protein, Beta1 integrin, which allows cells to interact and form the gut lining that protects the body from the intestinal contents.
We will test the importance of this protein in the repair of intestinal wounds and the factors which drive its role in wound repair. To achieve this, we will use reductionist models of the intestine that mimic the wound healing process and animal models of IBD. These models will allow us to manipulate Beta1 integrin in the hope of understanding the role it plays in wound healing. We will then use the knowledge gained from these studies, to examine human tissue from IBD patients, in the hope of identifying a trend in how Beta1 integrin contributes to the severity of IBD disease
Trial website
Trial related presentations / publications
Presentations:
2012 Experimental Biology Meeting, San Diego, USA
2010 American Gastroenterological Society, Gastrointestinal Injury meeting, Scottsdale, USA
2009 Advances in IBD Meeting, Florida, USA
2008 Experimental Biology Meeting, San Diego USA

Publications:
S. Keely, LE. Glover, CF. MacManus, EL. Campbell, MM. Scully, GT. Furuta, SP. Colgan Selective induction of integrin Beta1 by hypoxia-inducible factor (HIF): Implications for wound healing.
The FASEB Journal, 2009; 23(5): 1338-1346. IF:6.401, ERA Rank A

A. Robinson, S. Keely, J. Karhausen, ME. Gerich, GT. Furuta, SP. Colgan.
Mucosal Protection by Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibition.
Gastroenterology, 2008 134(1):145-155. IF:12.591, ERA Rank A*
Public notes

Contacts
Principal investigator
Name 34134 0
Address 34134 0
Country 34134 0
Phone 34134 0
Fax 34134 0
Email 34134 0
Contact person for public queries
Name 17381 0
Melissa Young
Address 17381 0
Research & Clinical Trials Coordinator Department of Gastroenterology
John Hunter Hospital, Department of Gastroenterology, Lookout Road New Lambton NSW 2305
Country 17381 0
Australia
Phone 17381 0
+61 2 4921 4853
Fax 17381 0
+61 2 4985 5978
Email 17381 0
[email protected]
Contact person for scientific queries
Name 8309 0
Simon Keely
Address 8309 0
Immunology & Microbiology
Rm 2413, Level 2 East Wing,
Hunter Medical Research Institute
School of Biomedical Sciences and Pharmacy
Faculty of Health
University of Newcastle
Callaghan NSW 2308
Country 8309 0
Australia
Phone 8309 0
+61 2 4042 0229
Fax 8309 0
+61 2 4042 0026
Email 8309 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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.