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Completed

NCT Number: NCT01534312

Casein Glycomacropeptide in Active Distal Ulcerative Colitis (Pilot Study)

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.

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Key information

Conditions

Colitis, Ulcerative Colitis Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of medicine V (Hepatology and Gastroenterology)

Aarhus C, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CGMP protein

Drug

Casein glycomacropeptide purified powder dissolved in 300 ML water once daily

Other names: Casein glycomacropeptide

Maximal oral 5ASA

Drug

4800 grams/day of Mesalazine (Asacol/Mezavant)

Other names: Asacol, Mezavant, Mesalazine

Primary outcomes

  1. Fecal calprotectin reduction

    Time frame: 4 weeks

    Relative reduction in fecal calprotectin measured before and after 4 weeks

Secondary outcomes

  1. Clinical activity index

    Time frame: 4 weeks

    Simple Clinical Colitis Index, range 0-20

  2. Quality of life

    Time frame: 4 weeks

    Quality of life measured yb Short Health Scale (4 items ranged 0-10, total range 0-40)

  3. Endoscopic Mayo score

    Time frame: 4 weeks

    Grade of inflammation (range 0-3) in rectum according to Mayo score, visually judged during endoscopy

  4. Serial fecal calprotectin

    Time frame: 8 weeks

    fecal calprotectin week 0-4-6-8

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Arla Foods

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 16, 2012
Registry last updated
Nov 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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