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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
36
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.
Centro Medico Teknon
Barcelona, Spain
The effect of Good Feeling Power® on gastrointestinal symptoms, biochemical biomarkers and endoscopic parameters
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).
Time frame: From baseline to Day180
Safety of Good Feeling Power® for patients with mild-to-moderate UC or CD
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.
Time frame: From baseline to Day180
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