Casein Glycomacropeptide in Active Distal Ulcerative Colitis (Pilot Study)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Casein Glycomacropeptide in Active Distal Ulcerative Colitis (Pilot Study)

Conditions
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Colitis, Ulcerative, Inflammatory Bowel Diseases

Intervention / Treatment
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* Drug: CGMP protein
* Drug: Maximal oral 5ASA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CGMP protein<br>Casein glycomacropeptide 30 gram/day, unchanged prophylactic 5ASA dose | Drug: CGMP protein<br>* Casein glycomacropeptide purified powder dissolved in 300 ML water once daily<br>* Other names: Casein glycomacropeptide;|
| Active Comparator: Standard oral 5ASA maximal dose<br>Increase from prophylactic dose 5ASA (mesalazine) to maximal oral dose, i.e. 4800 grams of mesalazine (Asacol/Mezavant) | Drug: Maximal oral 5ASA<br>* 4800 grams/day of Mesalazine (Asacol/Mezavant)<br>* Other names: Mesalazine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal calprotectin reduction | Relative reduction in fecal calprotectin measured before and after 4 weeks | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical activity index | Simple Clinical Colitis Index, range 0-20 | 4 weeks | 
| Quality of life | Quality of life measured yb Short Health Scale (4 items ranged 0-10, total range 0-40) | 4 weeks | 
| Endoscopic Mayo score | Grade of inflammation (range 0-3) in rectum according to Mayo score, visually judged during endoscopy | 4 weeks | 
| Serial fecal calprotectin | fecal calprotectin week 0-4-6-8 | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glycopeptides, Dietary proteins