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CAsein GLycomacropeptide in Ulcerative Colitis - Anti-Inflammatory and Microbiome Modulating Effects (CAGLUCIM) (CAGLUCIM)

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ClinicalTrials.gov Identifier: NCT02825914
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

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.


Condition or disease Intervention/treatment Phase
Colitis, Ulcerative Inflammatory Bowel Diseases Dietary Supplement: Casein glycomacropeptide (CGMP) Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CAsein GLycomacropeptide in Ulcerative Colitis - Anti-Inflammatory and Microbiome Modulating Effects (CAGLUCIM)
Actual Study Start Date : September 1, 2016
Actual Primary Completion Date : July 1, 2019
Actual Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Casein

Arm Intervention/treatment
Active Comparator: 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.
Dietary Supplement: Casein glycomacropeptide (CGMP)
Placebo Comparator: 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.
Dietary Supplement: Placebo



Primary Outcome Measures :
  1. Endoscopic remission [ Time Frame: 12 weeks ]
    The number of patients in endoscopic remission/macroscopic mucosal healing (Endoscopic Mayo Score of 0)

  2. Clinical remission [ Time Frame: 12 weeks ]
    The number of patients in clinical remission (SCCAI ≤ 2)

  3. Clinical Response [ Time Frame: 12 weeks ]
    The number of patients with clinical response (reduction of SCCAI-score of at least 2 points)

  4. Fecal inflammatory marker [ Time Frame: 12 weeks ]
    The number of patients with a fecal-calprotectin below 150 mg/kg


Secondary Outcome Measures :
  1. Endoscopic response [ Time Frame: 12 weeks ]
    The number of patients with endoscopic response (reduction of Endoscopic Mayo Score of at least 1point)

  2. Steroid-free remission [ Time Frame: 12 weeks ]
    The number of patients in steroid-free remission (SCCAI ≤ 2)

  3. Clinical remission at follow-up [ Time Frame: 26 weeks ]
    The number of patients in clinical remission (SCCAI ≤ 2)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825914


Locations
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Denmark
Department of medicine V (Hepatology and Gastroenterology)
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
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Study Chair: Hendrik A Vilstrup, Professor University of Aarhus
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02825914    
Other Study ID Numbers: CAGLUCIM2016
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020
Keywords provided by University of Aarhus:
glycopeptides
human microbiome
caseinomacropeptide
whey protein
dietary proteins
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Inflammatory Bowel Diseases
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Caseins
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action