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

Not Applicable

Completed

• Conditions: Colitis, Ulcerative; Inflammatory Bowel Diseases
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Casein glycomacropeptide (CGMP)

• Registration Number: NCT02825914
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-30
• Study First Submitted QC: 2016-07-04
• Study First Posted: 2016-07-07
• Study Start: 2016-09-01
• Primary Completion: 2019-07-01
• Study Completion: 2019-10-01
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-05
• Last Update Posted: 2020-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• ulcerative colitis (verified by mucosal histology and endoscopy)
• Clinically active ulcerative colitis (SCCAI ≥ 3)

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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.)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Casein glycomacropeptide (CGMP)	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of medicine V (Hepatology and Gastroenterology); 🇩🇰 Aarhus C, Denmark