CAsein GLycomacropeptide in Ulcerative Colitis - Anti-Inflammatory and Microbiome Modulating Effects (CAGLUCIM)

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. In a pilot study the investigators found, that orally administered CGMP seems to have a beneficial effect comparable to that of mesalazine in active distal ulcerative colitis. The investigators wish to evaluate the effects in a larger group of patients with active ulcerative colitis by studying the clinical effects and assessing the anti-inflammatory and microbiome modulating properties.

Official Title
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CAsein GLycomacropeptide in Ulcerative Colitis - Anti-Inflammatory and Microbiome Modulating Effects (CAGLUCIM)

Conditions
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Colitis, Ulcerative, Inflammatory Bowel Diseases

Intervention / Treatment
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* Dietary Supplement: Casein glycomacropeptide (CGMP)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ulcerative colitis (verified by mucosal histology and endoscopy) Clinically active ulcerative colitis (SCCAI ≥ 3) Exclusion Criteria: Endoscopically inactive disease (Endoscopic Mayo Score of 0) Lactose or milk protein intolerance Celiac disease Not able to understand or speak Danish. Pregnant or nursing. Growth of pathogenic bacteria in stool culture from 4 weeks before and until randomization (Salmonella, Campylobacter, Yersinia or Clostridium Difficile.)

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Casein glycomacropeptide (CGMP)<br>As add-on to the standard medical treatment of active ulcerative colitis the patients will receive a daily oral intake of CGMP-protein-shake during 12 weeks. | Dietary Supplement: Casein glycomacropeptide (CGMP)<br> <br> |
| Placebo Comparator: Placebo<br>As add-on to the standard medical treatment of active ulcerative colitis the patients will receive a daily oral intake of placebo-shake consisting of milk powder during 12 weeks. | Dietary Supplement: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopic remission | The number of patients in endoscopic remission/macroscopic mucosal healing (Endoscopic Mayo Score of 0) | 12 weeks | 
| Clinical remission | The number of patients in clinical remission (SCCAI ≤ 2) | 12 weeks | 
| Clinical Response | The number of patients with clinical response (reduction of SCCAI-score of at least 2 points) | 12 weeks | 
| Fecal inflammatory marker | The number of patients with a fecal-calprotectin below 150 mg/kg | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopic response | The number of patients with endoscopic response (reduction of Endoscopic Mayo Score of at least 1point) | 12 weeks | 
| Steroid-free remission | The number of patients in steroid-free remission (SCCAI ≤ 2) | 12 weeks | 
| Clinical remission at follow-up | The number of patients in clinical remission (SCCAI ≤ 2) | 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glycopeptides, human microbiome, caseinomacropeptide, whey protein, dietary proteins