An interventional study of CGMP protein and Maximal oral 5ASA in Colitis, Ulcerative and Inflammatory Bowel Diseases, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-22.
Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment
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. We hypothesize that orally administered CGMP has a beneficial effect comparable to that of mesalazine in active distal ulcerative colitis.
GCMP has mainly been used as food additive in patients with specific dietary needs, i.e. in infant formulas, adipositas, or in patient with phenylketonuria. Due to its antiinflammatory properties we hypothesize that it may be used alone or along with conventional therapy in inflammatory diseases such as ulcerative colitis.
1,074 studies on the registry are indexed under Colitis; 133 are open to participants now.
This study's enrollment of 24 is below the median of 60 across 771 interventional studies indexed under Colitis.
Browse Colitis studies →University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
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Exclusion Criteria:
Casein glycomacropeptide 30 gram/day, unchanged prophylactic 5ASA dose
Drug: CGMP protein
Increase from prophylactic dose 5ASA (mesalazine) to maximal oral dose, i.e. 4800 grams of mesalazine (Asacol/Mezavant)
Drug: Maximal oral 5ASA
Casein glycomacropeptide purified powder dissolved in 300 ML water once daily
Also known as: Casein glycomacropeptide
4800 grams/day of Mesalazine (Asacol/Mezavant)
Also known as: Asacol, Mezavant, Mesalazine
Fecal calprotectin reduction
Relative reduction in fecal calprotectin measured before and after 4 weeks
Time frame: 4 weeks
Clinical activity index
Simple Clinical Colitis Index, range 0-20
Time frame: 4 weeks
Quality of life
Quality of life measured yb Short Health Scale (4 items ranged 0-10, total range 0-40)
Time frame: 4 weeks
Endoscopic Mayo score
Grade of inflammation (range 0-3) in rectum according to Mayo score, visually judged during endoscopy
Time frame: 4 weeks
Serial fecal calprotectin
fecal calprotectin week 0-4-6-8
Time frame: 8 weeks
This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.
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University of Aarhus