Casein Glycomacropeptide in Active Distal Ulcerative Colitis (Pilot Study)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Aarhus
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Fecal calprotectin reduction
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
CGMP protein
Casein glycomacropeptide 30 gram/day, unchanged prophylactic 5ASA dose
Intervention: CGMP protein (Drug)
Standard oral 5ASA maximal dose
Increase from prophylactic dose 5ASA (mesalazine) to maximal oral dose, i.e. 4800 grams of mesalazine (Asacol/Mezavant)
Intervention: Maximal oral 5ASA (Drug)
Outcomes
Primary Outcomes
Fecal calprotectin reduction
Time Frame: 4 weeks
Relative reduction in fecal calprotectin measured before and after 4 weeks
Secondary Outcomes
- Clinical activity index(4 weeks)
- Quality of life(4 weeks)
- Endoscopic Mayo score(4 weeks)
- Serial fecal calprotectin(8 weeks)