Ulcerative Colitis
Conditions
Brief summary
The purpose of this study is to determine whether the lactic acid bacteria Lactobacillus acidophilus (LA5) and Bifidobacterium animalis subsp. lactis (BB12) is effective as maintenance treatment in ulcerative colitis.
Interventions
DRUGlactobacilus acidophilus & bifidobacterium animalis/lactis
Sponsors
Chr Hansen
Hvidovre University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with ulerative colitis ording to well-known diagnostic criteria and remission for at least one month, and with at least one relapse within the last year.
Exclusion criteria
* Pregnancy and lactating * Serious underlying disease other than UC * Former gastrointestinal resections * Medication for UC other than mesalazine * Known allergic reactions towards compounds in the study drug. * Expected lack of compliance due to mental state or language problems
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with relapse at 12 month. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of days to relapse. | — |
| Presence and concentrations of the probiotic bacterial strains in stool. | — |
| Safety and tolerance of the probiotic mixture. | — |
Countries
Denmark
Outcome results
None listed