Back to resultsCasein Glycomacropeptide in Active Distal Ulcerative Colitis (Pilot Study)
Primary Purpose
Colitis, Ulcerative, Inflammatory Bowel Diseases
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
CGMP protein
Maximal oral 5ASA
Sponsored by
About this trial
This is an interventional treatment trial for Colitis, Ulcerative focused on measuring Glycopeptides, Dietary proteins
Eligibility 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
Sites / Locations
- Department of medicine V (Hepatology and Gastroenterology)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CGMP protein
Standard oral 5ASA maximal dose
Arm Description
Casein glycomacropeptide 30 gram/day, unchanged prophylactic 5ASA dose
Increase from prophylactic dose 5ASA (mesalazine) to maximal oral dose, i.e. 4800 grams of mesalazine (Asacol/Mezavant)
Outcomes
Primary Outcome Measures
Fecal calprotectin reduction
Relative reduction in fecal calprotectin measured before and after 4 weeks
Secondary Outcome Measures
Clinical activity index
Simple Clinical Colitis Index, range 0-20
Quality of life
Quality of life measured yb Short Health Scale (4 items ranged 0-10, total range 0-40)
Endoscopic Mayo score
Grade of inflammation (range 0-3) in rectum according to Mayo score, visually judged during endoscopy
Serial fecal calprotectin
fecal calprotectin week 0-4-6-8
Full Information
NCT ID
NCT01534312
First Posted
February 13, 2012
Last Updated
November 20, 2016
Sponsor
University of Aarhus
Collaborators
Arla Foods
1. Study Identification
Unique Protocol Identification Number
NCT01534312
Brief Title
Casein Glycomacropeptide in Active Distal Ulcerative Colitis (Pilot Study)
Official Title
Casein Glycomacropeptide in Active Distal Ulcerative Colitis (Pilot Study)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Arla Foods
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Ulcerative, Inflammatory Bowel Diseases
Keywords
Glycopeptides, Dietary proteins
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CGMP protein
Arm Type
Experimental
Arm Description
Casein glycomacropeptide 30 gram/day, unchanged prophylactic 5ASA dose
Arm Title
Standard oral 5ASA maximal dose
Arm Type
Active Comparator
Arm Description
Increase from prophylactic dose 5ASA (mesalazine) to maximal oral dose, i.e. 4800 grams of mesalazine (Asacol/Mezavant)
Intervention Type
Drug
Intervention Name(s)
CGMP protein
Other Intervention Name(s)
Casein glycomacropeptide
Intervention Description
Casein glycomacropeptide purified powder dissolved in 300 ML water once daily
Intervention Type
Drug
Intervention Name(s)
Maximal oral 5ASA
Other Intervention Name(s)
Asacol, Mezavant, Mesalazine
Intervention Description
4800 grams/day of Mesalazine (Asacol/Mezavant)
Primary Outcome Measure Information:
Title
Fecal calprotectin reduction
Description
Relative reduction in fecal calprotectin measured before and after 4 weeks
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Clinical activity index
Description
Simple Clinical Colitis Index, range 0-20
Time Frame
4 weeks
Title
Quality of life
Description
Quality of life measured yb Short Health Scale (4 items ranged 0-10, total range 0-40)
Time Frame
4 weeks
Title
Endoscopic Mayo score
Description
Grade of inflammation (range 0-3) in rectum according to Mayo score, visually judged during endoscopy
Time Frame
4 weeks
Title
Serial fecal calprotectin
Description
fecal calprotectin week 0-4-6-8
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hendrik Vilstrup, Professor
Organizational Affiliation
Professor, University of Aarhus
Official's Role
Study Chair
Facility Information:
Facility Name
Department of medicine V (Hepatology and Gastroenterology)
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
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Casein Glycomacropeptide in Active Distal Ulcerative Colitis (Pilot Study)
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