CAsein GLycomacropeptide in Ulcerative Colitis - Anti-Inflammatory and Microbiome Modulating Effects (CAGLUCIM)
NCT ID: NCT02825914
Last Updated: 2020-04-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2016-09-01
2019-10-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Casein glycomacropeptide (CGMP)
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.
Casein glycomacropeptide (CGMP)
Placebo
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.
Placebo
Interventions
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Casein glycomacropeptide (CGMP)
Placebo
Eligibility Criteria
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Inclusion Criteria
* Clinically active ulcerative colitis (SCCAI ≥ 3)
Exclusion Criteria
* 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.)
18 Years
ALL
No
Sponsors
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University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Hendrik A Vilstrup, Professor
Role: STUDY_CHAIR
University of Aarhus
Locations
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Department of medicine V (Hepatology and Gastroenterology)
Aarhus C, , Denmark
Countries
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Other Identifiers
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CAGLUCIM2016
Identifier Type: -
Identifier Source: org_study_id
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