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

Inflammatory Bowel Diseases Clinical Trial

— CAGLUCIM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02825914
• Other study ID #: CAGLUCIM2016
• Status: Completed
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: October 1, 2019

Study information

• Verified date: April 2020
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Inflammatory Bowel Diseases
• Ulcer

Intervention

Dietary Supplement:
• Casein glycomacropeptide (CGMP)

• Placebo

Locations

Country	Name	City	State
Denmark	Department of medicine V (Hepatology and Gastroenterology)	Aarhus C

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endoscopic remission	The number of patients in endoscopic remission/macroscopic mucosal healing (Endoscopic Mayo Score of 0)	12 weeks
Primary	Clinical remission	The number of patients in clinical remission (SCCAI = 2)	12 weeks
Primary	Clinical Response	The number of patients with clinical response (reduction of SCCAI-score of at least 2 points)	12 weeks
Primary	Fecal inflammatory marker	The number of patients with a fecal-calprotectin below 150 mg/kg	12 weeks
Secondary	Endoscopic response	The number of patients with endoscopic response (reduction of Endoscopic Mayo Score of at least 1point)	12 weeks
Secondary	Steroid-free remission	The number of patients in steroid-free remission (SCCAI = 2)	12 weeks
Secondary	Clinical remission at follow-up	The number of patients in clinical remission (SCCAI = 2)	26 weeks