ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Crohn's Disease

Condition category

Condition code

Oral and Gastrointestinal

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]

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]

Identification of major mechanisms of mucosal wound healing in active Crohn's inflammation

Timepoint [1]

During active inflammation and during remission

Secondary outcome [1]

Possible proof of principle for therapeutic strategy to promote wound healing during active inflammation

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

University of Newcastle

Address

University Drive,
Callaghan
2308 NSW

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Hunter Medical Research Institute - John Hunter Hospital

Address [1]

John Hunter Hospital
Lookout Road,
New Lambton Heights
2310 NSW

Country [1]

Australia

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Hunter New England Human Research Ethics Committee (EC00403)

Ethics committee address [1]

Hunter New England Health
Locked Bag 1
NEW LAMBTON NSW 2305

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

03/05/2012

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Melissa Young

Address

Research & Clinical Trials Coordinator Department of Gastroenterology
John Hunter Hospital, Department of Gastroenterology, Lookout Road New Lambton NSW 2305

Country

Australia

Phone

+61 2 4921 4853

Fax

+61 2 4985 5978

melissa.young@hnehealth.nsw.gov.au

Contact person for scientific queries

Name

Simon Keely

Address

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

Australia

Phone

+61 2 4042 0229

Fax

+61 2 4042 0026

Simon.Keely@newcastle.edu.au

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.

Trial Review

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