Crohn Disease (CD), Ulcerative Colitis (UC)
Conditions
Brief summary
This open-label pilot study aims to evaluate the safety and efficacy of the dietary supplement Good Feeling Power® for patients with mild-to-moderate ulcerative colitis and colonic/ileal Crohn's disease.
Interventions
The dietary supplement Good Feeling Power®, isolated from the fruiting bodies of the tree mushroom (tinder fungus, lat. Fomes fomentarius), was administered orally as a drink.
Sponsors
Study design
Eligibility
Inclusion criteria
* Adults aged 18 - 64 * BMI 18.5 - 32.0 kg/m² * Mild-to-moderate UC or colonic/ileal CD * At least one prior episode of active disease
Exclusion criteria
* Extensive colonic resection or subtotal or total colectomy * Currently required or anticipated surgical intervention during the study * Any prior exposure to natalizumab, efalizumab, or rituximab * History or evidence of colonic mucosal dysplasia * Female patients who are lactating or have a positive pregnancy test * Any unstable or uncontrolled medical disorder that, in the opinion of the investigator, would confound the study results or compromise patient safety.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The effect of Good Feeling Power® on gastrointestinal symptoms, biochemical biomarkers and endoscopic parameters | From baseline to Day180 | The primary outcomes are the changes in gastrointestinal symptoms (Simple Clinical Colitis Activity Index for ulcerative colitis (UC) patients and the Harvey-Bradshaw Index for Crohn's disease (CD) patients), biochemical biomarkers in feces (calprotectin, immunoglobulin A, hemoglobin), and endoscopic parameters (Mayo Endoscopic Score). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Good Feeling Power® for patients with mild-to-moderate UC or CD | From baseline to Day180 | The secondary outcomes are the safety of the tested product, as monitored by vital signs, ECG, physical condition, blood parameters (hematology, clinical chemistry, coagulation, and inflammation), urine analysis, and the absence of the product-related adverse effects. |
Countries
Spain