Casein Glycomacropeptide in Active Distal Ulcerative Colitis (Pilot Study)

University of Aarhus

Status: Completed

Conditions: Colitis, Ulcerative; Inflammatory Bowel Diseases

Treatments: Drug: CGMP protein; Drug: Maximal oral 5ASA

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01534312

CGMP in UC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 years or more
• Diagnosed ulcerative colitis
• Signs of clinical activity with SCCAI of 3 or more
• Extension more than 10 cm and no more than 40 cm from anus

Exclusion criteria

• Rectal temperature more than 38 degrees Celcius
• Diagnosed celiac disease or lactose intolerance
• Unable to speak or understand Danish
• Prior biologics or systemic steroids 4 weeks up to inclusion

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

CGMP protein

Experimental group

Description:

Casein glycomacropeptide 30 gram/day, unchanged prophylactic 5ASA dose

Treatment:

Drug: CGMP protein

Standard oral 5ASA maximal dose

Active Comparator group

Description:

Increase from prophylactic dose 5ASA (mesalazine) to maximal oral dose, i.e. 4800 grams of mesalazine (Asacol/Mezavant)

Treatment:

Drug: Maximal oral 5ASA