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

University of Aarhus

Status: Completed

Conditions: Colitis, Ulcerative; Inflammatory Bowel Diseases

Treatments: Dietary Supplement: Casein glycomacropeptide (CGMP); Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02825914

CAGLUCIM2016

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Casein glycomacropeptide (CGMP)

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Casein glycomacropeptide (CGMP)

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo