NCT01534312

Casein Glycomacropeptide in Active Distal Ulcerative Colitis (Pilot Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Colitis, Ulcerative
• Inflammatory Bowel Diseases

Interventions

Type	Name	Description
DRUG	CGMP protein	Casein glycomacropeptide purified powder dissolved in 300 ML water once daily
DRUG	Maximal oral 5ASA	4800 grams/day of Mesalazine (Asacol/Mezavant)

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-09-01
• Completion: 2014-12-01
• First posted: 2012-02-16
• Last updated: 2016-11-22

Locations

1 site across 1 country: Denmark