Last reviewed · How we verify

NCT02825914: CAGLUCIM

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

Completed NA Last updated 7 April 2020
What this trial tests

NA trial testing Casein glycomacropeptide (CGMP) in Colitis, Ulcerative in 80 participants. Completed in 1 October 2019.

Timeline
1 September 2016
Primary endpoint
1 July 2019
1 October 2019

Quick facts

Lead sponsorUniversity of Aarhus
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment80
Start date1 September 2016
Primary completion1 July 2019
Estimated completion1 October 2019
Sites1 location across Denmark

Drugs / interventions tested

Conditions studied

Sponsor

University of Aarhus

Who can join

18 and older, any sex, with Colitis, Ulcerative or Inflammatory Bowel Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Microbial-Based and Microbial-Targeted Therapies for Inflammatory Bowel Diseases.
    Oka A, Sartor RB. · · 2020 · cited 126× · PMID 32006212 · DOI 10.1007/s10620-020-06090-z

Verify or expand the search:

Other trials of Casein glycomacropeptide (CGMP)

Trials testing the same drug.

Other recruiting trials for Colitis, Ulcerative

Currently open trials in the same condition.

Other University of Aarhus trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02825914.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing