Ulcerative Colitis
Conditions
Keywords
IBD, UC, Profermin, Fresubin, Probiotics, Dietetic
Brief summary
This study aim to investigate the effect of Profermin versus Fresubin in the dietetic treatment of active ulcerative colitis.
Interventions
Sponsors
Hvidovre University Hospital
Nordisk Rebalance A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Active ulcerative colitis (SCCAI =\>5 and \<=11) * Access to Internet
Exclusion criteria
* Stoma or intestinal resections * Recent changes in UC medication * Treatment with antibiotics * Diabetes * Celiac disease * Lactose malabsorption
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Development in Simple Clinical Colitis Activity Index (SCCAI) score | 8 and 16 weeks | Clinical significant difference (\>1.5) in course of SCCAI score between the two intervention groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical remission | 8 and 16 weeks | Proportion of patients in clinical remission (SCCAI=\<2.5) |
| Safety - Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 20 weeks | — |
| Reduction in SCCAI score | 8 and 16 weeks | Proportion of patients with a reduction in SCCAI above 1.5, 3.0 and 4.5 |
Countries
Denmark
Outcome results
None listed