- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01534312
Casein Glycomacropeptide in Active Distal Ulcerative Colitis (Pilot Study)
November 20, 2016 updated by: University of Aarhus
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Aarhus C, Denmark, 8000
- Department of medicine V (Hepatology and Gastroenterology)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CGMP protein
Casein glycomacropeptide 30 gram/day, unchanged prophylactic 5ASA dose
|
Casein glycomacropeptide purified powder dissolved in 300 ML water once daily
Other Names:
|
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)
|
4800 grams/day of Mesalazine (Asacol/Mezavant)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fecal calprotectin reduction
Time Frame: 4 weeks
|
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
Time Frame: 4 weeks
|
Simple Clinical Colitis Index, range 0-20
|
4 weeks
|
Quality of life
Time Frame: 4 weeks
|
Quality of life measured yb Short Health Scale (4 items ranged 0-10, total range 0-40)
|
4 weeks
|
Endoscopic Mayo score
Time Frame: 4 weeks
|
Grade of inflammation (range 0-3) in rectum according to Mayo score, visually judged during endoscopy
|
4 weeks
|
Serial fecal calprotectin
Time Frame: 8 weeks
|
fecal calprotectin week 0-4-6-8
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Hendrik Vilstrup, Professor, Professor, University of Aarhus
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
February 13, 2012
First Submitted That Met QC Criteria
February 13, 2012
First Posted (Estimate)
February 16, 2012
Study Record Updates
Last Update Posted (Estimate)
November 22, 2016
Last Update Submitted That Met QC Criteria
November 20, 2016
Last Verified
December 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Gastrointestinal Diseases
- Gastroenteritis
- Colonic Diseases
- Intestinal Diseases
- Ulcer
- Inflammatory Bowel Diseases
- Colitis
- Colitis, Ulcerative
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Mesalamine
Other Study ID Numbers
- CGMP in UC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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