Ulcerative Colitis
Conditions
Keywords
Fecal Microbiota Transplantation
Brief summary
7 patients with active Ulcerative Colitis are treated with 25 multi-donor FMT Capsules daily for 50 days.
Detailed description
7 patients with active Ulcerative Colitis are treated with 25 multi-donor FMT Capsules daily for 50 days All patients are followed with regular follow up after 2,4,8,12,16, 20 and 24 weeks.
Interventions
25 daily multi-donor FMT Capsules for 50 days
Sponsors
Alice Højer Christensen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The trial is an open-label pilot study treating 7 patients with Ulcerative Colitis with 25 daily multi-donor FMT Capsules for 50 days with 6 months follow up including the treatment period
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with Ulcerative Colitis (UC) * SCCAI between 4 and 10 at inclusion * On a stable dose of 5-aminosalicylic acid (5-ASA) or without current treatment. * Previous treatment with glucocorticoids, thiopurines and/or biological treatment was accepted. * Fecal Calprotectin \> 250 mg/kg * Colonoscopy performed within the last 3 years * Capable of writing and speaking Danish * Attending regular follow-ups by a specialist in gastroenterology.
Exclusion criteria
* Biological treatment within the last four weeks * Treatment with antibiotics within 48 hours before intervention * Alcohol use above current Danish guidelines (14 units/week for men and 7 units/week for women) * Pregnancy or planned pregnancy * Active cancer disease * Medical treatment of mental disorder * Other chronic gastroenterological disorder besides UC, Irritable Bowel Syndrome (IBS) or Reflux-disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in patient colitis symptoms as assessed using the Simple Colitis Clinical Activity Index (SCCAI) | Baseline, 2,8,16 and 24 weeks | Simple Colitis Clinical Activity Index (SCCAI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fecal microbiota biodiversity in patients with Ulcerative Colitis and difference to donors fecal microbiota diversity | Baseline | Alpha diversity (Shannon-index) |
| Fecal microbiota biodiversity in fecal donors | At donor inclusion | Alpha diversity (Shannon-index) |
| Changes in fecal microbiota biodiversity in patients with Ulcerative Colitis in comparison with value at baseline | 8, 16 and 24 weeks | Alpha diversity (Shannon-index) |
| Changes in Fecal Calprotectin in the active treatment period and follow-up period | Baseline, 8,16 and 24 weeks | Fecal Calprotectin |
| Changes in patient reported quality of life: IBDQ | Baseline, 8, 16 and 24 weeks | Inflammatory Bowel Disease Questionnaire (IBDQ) |
Countries
Denmark
Outcome results
None listed