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Trial registered on ANZCTR


Registration number
ACTRN12614000465651
Ethics application status
Approved
Date submitted
28/04/2014
Date registered
2/05/2014
Date last updated
24/01/2019
Date data sharing statement initially provided
24/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigation of the safety and effectiveness of Dietzia C79793-74 for moderate to severe Crohn's disease
Scientific title
Single centre, open label Phase 1/Phase 2 study to evaluate the safety and efficacy of Dietzia C79793-74 in moderate to severe Crohn's disease
Secondary ID [1] 284496 0
Nil
Universal Trial Number (UTN)
U1111-1156-1026
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's disease 291747 0
Condition category
Condition code
Oral and Gastrointestinal 292115 292115 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients in this study will be allocated to receive active treatment with the bacteria Dietzia C79793-74. Dietzia C79793-74 will be given as a probiotic suspension of a 10^11 cells/mL, to be mixed in to milk-based beverage once a day for 8 weeks. Each patient will receive a constant dose, however the volume of the dose will depend on body weight and will range between 1-3 mL.

Compliance will be assessed by the return of unused doses at study visits.

Patients in this study will be involved for up to 8 weeks prior to receiving Dietzia C79793-74 and will be followed up for 12 weeks after completing their final Dietzia C79793-74 dose. They will be required to attend a total of 10 study visits over a six month period.
Intervention code [1] 289255 0
Treatment: Other
Comparator / control treatment
This is an open-label study: all patients will receive the investigational treatment.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291991 0
Clinical safety as determined by laboratory tests, vital signs, 12-lead electrocardiogram, physical examination, urinalysis, blood culture and adverse event reporting.
Timepoint [1] 291991 0
Throughout study from Baseline (Day -28) to Day 140
Secondary outcome [1] 307973 0
Improvment in Crohn's disease activity index (CDAI)
Timepoint [1] 307973 0
At 8 weeks (conclusion of Dietzia C79793-74 dosing)
Secondary outcome [2] 307974 0
Improvement in health-related quality of life using the Inflammatory Bowel Disease Questionnaire (IBDQ)
Timepoint [2] 307974 0
At 8 weeks (conclusion of Dietzia C79793-73 dosing)

Eligibility
Key inclusion criteria
- Males and females of non-childbearing potential, aged 18-75
- Diagnosis of moderate to severe Crohn's disease
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Females of childbearing potential, pregnant or lactating females
- Unwilling to practice two effective methods of contraception
- A diagnosis of ulcerative colitis, pouchitis, indeterminate colitis
- Any other significant GI condition
- Evidence of cardiac impairment, insufficiency or disease, particularly cardiac valvular disease
- Severe hepatic or renal disease or impairment
- Known diagnosis with Type 2 diabetes mellitus
- History of or current infection with rheumatic fever
- Major immunodeficiency or immunosuppression
- Recently taken, actively taking or are expected to require prohibited medications

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This study is open-label: allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This study is open-label: subjects will not be randomised.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/05/2014
Actual
19/01/2015
Date of last participant enrolment
Anticipated
Actual
17/11/2015
Date of last data collection
Anticipated
Actual
11/02/2016
Sample size
Target
6
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2365 0
Centre for Digestive Diseases - Five Dock
Recruitment postcode(s) [1] 8031 0
2046 - Five Dock

Funding & Sponsors
Funding source category [1] 289142 0
Hospital
Name [1] 289142 0
Investigator-initiated. Internally sponsored by CDD
Country [1] 289142 0
Australia
Primary sponsor type
Hospital
Name
Centre for Digestive Diseases
Address
Level 1, 229 Great North Road
Five Dock, NSW 2046
Country
Australia
Secondary sponsor category [1] 287807 0
None
Name [1] 287807 0
Address [1] 287807 0
Country [1] 287807 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290917 0
Centre for Digestive Diseases Human Research Ethics Committee
Ethics committee address [1] 290917 0
Level 1, 229 Great North Road
Five Dock, NSW 2046
Ethics committee country [1] 290917 0
Australia
Date submitted for ethics approval [1] 290917 0
28/01/2014
Approval date [1] 290917 0
24/03/2014
Ethics approval number [1] 290917 0

Summary
Brief summary
The purpose of this study is to see if treatment with Dietzia C79793-74 in patients with Crohn's disease is safe and effective in reducing disease severity and improving quality-of-life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47954 0
Prof Thomas Borody
Address 47954 0
Centre for Digestive Diseases
Level 1, 229 Great North Road
Five Dock, NSW 2046
Country 47954 0
Australia
Phone 47954 0
+61297134011
Fax 47954 0
Email 47954 0
[email protected]
Contact person for public queries
Name 47955 0
Sarah Finlayson
Address 47955 0
Centre for Digestive Diseases
Level 1, 229 Great North Road
Five Dock, NSW 2046
Country 47955 0
Australia
Phone 47955 0
+61297134011
Fax 47955 0
Email 47955 0
[email protected]
Contact person for scientific queries
Name 47956 0
Sarah Finlayson
Address 47956 0
Centre for Digestive Diseases
Level 1, 229 Great North Road
Five Dock, NSW 2046
Country 47956 0
Australia
Phone 47956 0
+61297134011
Fax 47956 0
Email 47956 0
[email protected]

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


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.