Ulcerative Colitis, Crohn´s disease
Conditions
Brief summary
Steroid free clinical remission at week 14 from first fecal microbiota transplant and week 12 from the first infliximab/vedolizumab infusion. Clinical remission here is defined as a total score of ≤2 on the Mayo scale and no subscore >1 on any of the four components.
Detailed description
Endoscopic healing defined as endoscopic Mayo subscore of 0, Endoscopic improvement defined as Mayo endoscopic subscore of 0 or 1, Improvement in quality of life (defined as an increase of ≥16 points in IBDQ score), Histologic remission, Fecal calprotectin, Weight, Blood pressure, Clinical response defined as a reduction in the partial Mayo score (stool frequency, rectal bleeding, and physician's global assessment) of ≥2 points and of ≥25% from baseline, with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point., Adherence to FMT, Adverse events
Interventions
Sponsors
Varsinais-Suomen hyvinvointialue
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Steroid free clinical remission at week 14 from first fecal microbiota transplant and week 12 from the first infliximab/vedolizumab infusion. Clinical remission here is defined as a total score of ≤2 on the Mayo scale and no subscore >1 on any of the four components. | — |
Secondary
| Measure | Time frame |
|---|---|
| Endoscopic healing defined as endoscopic Mayo subscore of 0, Endoscopic improvement defined as Mayo endoscopic subscore of 0 or 1, Improvement in quality of life (defined as an increase of ≥16 points in IBDQ score), Histologic remission, Fecal calprotectin, Weight, Blood pressure, Clinical response defined as a reduction in the partial Mayo score (stool frequency, rectal bleeding, and physician's global assessment) of ≥2 points and of ≥25% from baseline, with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point., Adherence to FMT, Adverse events | — |
Countries
Finland
Outcome results
None listed