Back to resultsCAsein GLycomacropeptide in Ulcerative Colitis - Anti-Inflammatory and Microbiome Modulating Effects (CAGLUCIM) (CAGLUCIM)
Primary Purpose
Colitis, Ulcerative, Inflammatory Bowel Diseases
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Casein glycomacropeptide (CGMP)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Colitis, Ulcerative focused on measuring glycopeptides, human microbiome, caseinomacropeptide, whey protein, dietary proteins
Eligibility Criteria
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.)
Sites / Locations
- Department of medicine V (Hepatology and Gastroenterology)
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Casein glycomacropeptide (CGMP)
Placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Endoscopic remission
The number of patients in endoscopic remission/macroscopic mucosal healing (Endoscopic Mayo Score of 0)
Clinical remission
The number of patients in clinical remission (SCCAI ≤ 2)
Clinical Response
The number of patients with clinical response (reduction of SCCAI-score of at least 2 points)
Fecal inflammatory marker
The number of patients with a fecal-calprotectin below 150 mg/kg
Secondary Outcome Measures
Endoscopic response
The number of patients with endoscopic response (reduction of Endoscopic Mayo Score of at least 1point)
Steroid-free remission
The number of patients in steroid-free remission (SCCAI ≤ 2)
Clinical remission at follow-up
The number of patients in clinical remission (SCCAI ≤ 2)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02825914
Brief Title
CAsein GLycomacropeptide in Ulcerative Colitis - Anti-Inflammatory and Microbiome Modulating Effects (CAGLUCIM)
Acronym
CAGLUCIM
Official Title
CAsein GLycomacropeptide in Ulcerative Colitis - Anti-Inflammatory and Microbiome Modulating Effects (CAGLUCIM)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
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. 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.
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, human microbiome, caseinomacropeptide, whey protein, dietary proteins
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Casein glycomacropeptide (CGMP)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Casein glycomacropeptide (CGMP)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Endoscopic remission
Description
The number of patients in endoscopic remission/macroscopic mucosal healing (Endoscopic Mayo Score of 0)
Time Frame
12 weeks
Title
Clinical remission
Description
The number of patients in clinical remission (SCCAI ≤ 2)
Time Frame
12 weeks
Title
Clinical Response
Description
The number of patients with clinical response (reduction of SCCAI-score of at least 2 points)
Time Frame
12 weeks
Title
Fecal inflammatory marker
Description
The number of patients with a fecal-calprotectin below 150 mg/kg
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Endoscopic response
Description
The number of patients with endoscopic response (reduction of Endoscopic Mayo Score of at least 1point)
Time Frame
12 weeks
Title
Steroid-free remission
Description
The number of patients in steroid-free remission (SCCAI ≤ 2)
Time Frame
12 weeks
Title
Clinical remission at follow-up
Description
The number of patients in clinical remission (SCCAI ≤ 2)
Time Frame
26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hendrik A Vilstrup, Professor
Organizational Affiliation
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
Learn more about this trial
CAsein GLycomacropeptide in Ulcerative Colitis - Anti-Inflammatory and Microbiome Modulating Effects (CAGLUCIM)
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