Casein glycomacropeptide (CGMP) has anti-inflammatory properties in experimental rodent colitis and using human in vitro inflammation models. Its use as a food ingredient has proven safe and with no influence on dietary intake. In a pilot study the investigators found, that orally administered CGMP seems to have a beneficial effect comparable to that of mesalazine in active distal ulcerative colitis. The investigators wish to evaluate the effects in a larger group of patients with active ulcerative colitis by studying the clinical effects and assessing the anti-inflammatory and microbiome modulating properties.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Department of medicine V (Hepatology and Gastroenterology)
Aarhus C, Denmark
Endoscopic remission
The number of patients in endoscopic remission/macroscopic mucosal healing (Endoscopic Mayo Score of 0)
Time frame: 12 weeks
Clinical remission
The number of patients in clinical remission (SCCAI ≤ 2)
Time frame: 12 weeks
Clinical Response
The number of patients with clinical response (reduction of SCCAI-score of at least 2 points)
Time frame: 12 weeks
Fecal inflammatory marker
The number of patients with a fecal-calprotectin below 150 mg/kg
Time frame: 12 weeks
Endoscopic response
The number of patients with endoscopic response (reduction of Endoscopic Mayo Score of at least 1point)
Time frame: 12 weeks
Steroid-free remission
The number of patients in steroid-free remission (SCCAI ≤ 2)
Time frame: 12 weeks
Clinical remission at follow-up
The number of patients in clinical remission (SCCAI ≤ 2)
Time frame: 26 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.