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Casein Glycomacropeptide in Active Distal Ulcerative Colitis (Pilot Study)

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ClinicalTrials.gov Identifier: NCT01534312
Recruitment Status : Completed
First Posted : February 16, 2012
Last Update Posted : November 22, 2016
Arla Foods
Information provided by (Responsible Party):
University of Aarhus

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.

Condition or disease Intervention/treatment
Colitis, Ulcerative Inflammatory Bowel Diseases Drug: CGMP protein Drug: Maximal oral 5ASA

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Casein Glycomacropeptide in Active Distal Ulcerative Colitis (Pilot Study)
Study Start Date : January 2012
Primary Completion Date : September 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: CGMP protein
Casein glycomacropeptide 30 gram/day, unchanged prophylactic 5ASA dose
Drug: CGMP protein
Casein glycomacropeptide purified powder dissolved in 300 ML water once daily
Other Name: Casein glycomacropeptide
Active Comparator: Standard oral 5ASA maximal dose
Increase from prophylactic dose 5ASA (mesalazine) to maximal oral dose, i.e. 4800 grams of mesalazine (Asacol/Mezavant)
Drug: Maximal oral 5ASA
4800 grams/day of Mesalazine (Asacol/Mezavant)
Other Names:
  • Asacol
  • Mezavant
  • Mesalazine

Primary Outcome Measures :
  1. Fecal calprotectin reduction [ Time Frame: 4 weeks ]
    Relative reduction in fecal calprotectin measured before and after 4 weeks

Secondary Outcome Measures :
  1. Clinical activity index [ Time Frame: 4 weeks ]
    Simple Clinical Colitis Index, range 0-20

  2. Quality of life [ Time Frame: 4 weeks ]
    Quality of life measured yb Short Health Scale (4 items ranged 0-10, total range 0-40)

  3. Endoscopic Mayo score [ Time Frame: 4 weeks ]
    Grade of inflammation (range 0-3) in rectum according to Mayo score, visually judged during endoscopy

  4. Serial fecal calprotectin [ Time Frame: 8 weeks ]
    fecal calprotectin week 0-4-6-8

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01534312

Department of medicine V (Hepatology and Gastroenterology)
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Arla Foods
Study Chair: Hendrik Vilstrup, Professor Professor, University of Aarhus

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01534312     History of Changes
Other Study ID Numbers: CGMP in UC
First Posted: February 16, 2012    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: December 2012

Keywords provided by University of Aarhus:
Dietary proteins

Additional relevant MeSH terms:
Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents