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

April 5, 2020 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. 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

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

  • Denmark
      • 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:

  • 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.)

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endoscopic remission
Time Frame: 12 weeks
The number of patients in endoscopic remission/macroscopic mucosal healing (Endoscopic Mayo Score of 0)
12 weeks
Clinical remission
Time Frame: 12 weeks
The number of patients in clinical remission (SCCAI ≤ 2)
12 weeks
Clinical Response
Time Frame: 12 weeks
The number of patients with clinical response (reduction of SCCAI-score of at least 2 points)
12 weeks
Fecal inflammatory marker
Time Frame: 12 weeks
The number of patients with a fecal-calprotectin below 150 mg/kg
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endoscopic response
Time Frame: 12 weeks
The number of patients with endoscopic response (reduction of Endoscopic Mayo Score of at least 1point)
12 weeks
Steroid-free remission
Time Frame: 12 weeks
The number of patients in steroid-free remission (SCCAI ≤ 2)
12 weeks
Clinical remission at follow-up
Time Frame: 26 weeks
The number of patients in clinical remission (SCCAI ≤ 2)
26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 (ACTUAL)

September 1, 2016

Primary Completion (ACTUAL)

July 1, 2019

Study Completion (ACTUAL)

October 1, 2019

Study Registration Dates

First Submitted

June 30, 2016

First Submitted That Met QC Criteria

July 4, 2016

First Posted (ESTIMATE)

July 7, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 7, 2020

Last Update Submitted That Met QC Criteria

April 5, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAGLUCIM2016

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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