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Completed

NCT Number: NCT02825914

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

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.

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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

Who can participate

Healthy volunteers accepted: No

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

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.)

Treatment and study plan

Casein glycomacropeptide (CGMP)

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Acronym: CAGLUCIM

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 7, 2016
Registry last updated
Apr 7, 2020

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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