None listed
Conditions
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.
Interventions
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
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.
Sponsors
Centre for Digestive Diseases
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
- Males and females of non-childbearing potential, aged 18-75 - Diagnosis of moderate to severe Crohn's disease
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
Outcome results
None listed