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Casein Glycomacropeptide in Active Distal Ulcerative Colitis (Pilot Study)

This study is currently recruiting participants.
Verified December 2012 by University of Aarhus
Sponsor:
Collaborator:
Arla Foods
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01534312
First received: February 13, 2012
Last updated: December 14, 2012
Last verified: December 2012
History of Changes
  Purpose

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 Intervention Phase
Colitis, Ulcerative
Inflammatory Bowel Diseases
 Drug: CGMP protein
Drug: Maximal oral 5ASA
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Casein Glycomacropeptide in Active Distal Ulcerative Colitis (Pilot Study)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Fecal calprotectin reduction [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Relative reduction in fecal calprotectin measured before and after 4 weeks treatment: DIFF = ((FCALPbefore - FCALPafter)/FCALPbefore)*100 percent


Secondary Outcome Measures:
  • Clinical Activity Index [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Simple Colitis Activity Index (range 0-20)

  • Quality of life [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Quality of life measured yb Short Health Scale (4 items ranged 0-10, total range 0-40)

  • Endoscopic Mayo score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Grade of inflammation (range 0-3) in rectum according to Mayo score, visually judged during endoscopy

  • Serial fecal calprotectin [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    fecal calprotectin week 0-2-4-6-8


Estimated Enrollment: 40
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01534312

Contacts
Contact: Jørgen S Agnholt, MD PhD +4589493895 jorgen.agnholt@aarhus.rm.dk
Contact: Christian L Hvas, MD PhD +4589493895 chrishva@rm.dk

Locations
Denmark
Department of medicine V (Hepatology and Gastroenterology) Recruiting
Aarhus C, Denmark, 8000
Contact: Jørgen S Agnholt, MD PhD     +4589493895     jorgen.agnholt@aarhus.rm.dk    
Contact: Christian L Hvas, MD PhD     +4578463895     chrishva@rm.dk    
Principal Investigator: Jørgen S Agnholt, MD PhD            
Sub-Investigator: Christian L Hvas, MD PhD            
Sub-Investigator: Jens F Dahlerup, MD DMSci            
Sub-Investigator: Lisbet A Christensen, MD DMSci            
Sub-Investigator: Anders K Dige, MD            
Sponsors and Collaborators
University of Aarhus
Arla Foods
Investigators
Study Chair: Hendrik Vilstrup, Professor Professor, University of Aarhus
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01534312     History of Changes
Other Study ID Numbers: CGMP in UC
Study First Received: February 13, 2012
Last Updated: December 14, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Glycopeptides
Dietary proteins

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Inflammatory Bowel Diseases
Intestinal Diseases
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes
Caseins
Mesalamine
Chelating Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 18, 2013