Trial registered on ANZCTR


Trial ID
ACTRN12614000465651
Ethics application status
Approved
Date submitted
28/04/2014
Date registered
2/05/2014
Date last updated
6/09/2016
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
Gender
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
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Current
Final
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
Address [1] 289142 0
Centre for Digestive Diseases
Level 1, 229 Great North Road
Five Dock NSW 2046
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
cddresearch@cdd.com.au
Contact person for public queries
Name 47955 0
Miss 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
cddresearch@cdd.com.au
Contact person for scientific queries
Name 47956 0
Miss 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
cddresearch@cdd.com.au