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

NCT02825914 | Completed DMC

• 1 other identifier: CAGLUCIM2016
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Keywords

glycopeptides; human microbiome; caseinomacropeptide; whey protein; dietary proteins

Outcome Measures

Primary Outcomes (4)

• Endoscopic remission

  The number of patients in endoscopic remission/macroscopic mucosal healing (Endoscopic Mayo Score of 0)

  12 weeks

• Clinical remission

  The number of patients in clinical remission (SCCAI ≤ 2)

  12 weeks

• Clinical Response

  The number of patients with clinical response (reduction of SCCAI-score of at least 2 points)

  12 weeks

• Fecal inflammatory marker

  The number of patients with a fecal-calprotectin below 150 mg/kg

  12 weeks

Secondary Outcomes (3)

• Endoscopic response

  12 weeks

• Steroid-free remission

  12 weeks

• Clinical remission at follow-up

  26 weeks

Study Arms (2)

Casein glycomacropeptide (CGMP)

ACTIVE COMPARATOR

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.

Dietary Supplement: Casein glycomacropeptide (CGMP)

Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Interventions

Casein glycomacropeptide (CGMP) DIETARY_SUPPLEMENT

Casein glycomacropeptide (CGMP)

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of medicine V (Hepatology and Gastroenterology)

Aarhus C, 8000, Denmark

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Hendrik A Vilstrup, Professor

  University of Aarhus

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: July 7, 2016
• Study Start: September 1, 2016
• Primary Completion: July 1, 2019
• Study Completion: October 1, 2019
• Last Updated: April 7, 2020

Record last verified: 2020-04

Locations

DK (1)