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

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:
  • Casein glycomacropeptide
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:
  • Mesalazine
  • Mezavant
  • Asacol

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.

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

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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