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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02825914

Acronym

CAGLUCIM

Enrollment

Registered

2016-07-07

Start date

2016-09-01

Completion date

2019-10-01

Last updated

2020-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colitis, Ulcerative, Inflammatory Bowel Diseases

Keywords

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

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.

Interventions

DIETARY_SUPPLEMENTCasein glycomacropeptide (CGMP)

DIETARY_SUPPLEMENTPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.)

Design outcomes

Primary

Measure	Time frame	Description
Clinical Response	12 weeks	The number of patients with clinical response (reduction of SCCAI-score of at least 2 points)
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)
Endoscopic remission	12 weeks	The number of patients in endoscopic remission/macroscopic mucosal healing (Endoscopic Mayo Score of 0)

Secondary

Measure	Time frame	Description
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)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026