Casein Glycomacropeptide in Active Distal Ulcerative Colitis (Pilot Study)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01534312

Enrollment

Registered

2012-02-16

Start date

2012-01-31

Completion date

2014-12-31

Last updated

2016-11-22

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, 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. We hypothesize that orally administered CGMP has a beneficial effect comparable to that of mesalazine in active distal ulcerative colitis.

Detailed description

GCMP has mainly been used as food additive in patients with specific dietary needs, i.e. in infant formulas, adipositas, or in patient with phenylketonuria. Due to its antiinflammatory properties we hypothesize that it may be used alone or along with conventional therapy in inflammatory diseases such as ulcerative colitis.

Interventions

DRUGCGMP protein

Casein glycomacropeptide purified powder dissolved in 300 ML water once daily

DRUGMaximal oral 5ASA

4800 grams/day of Mesalazine (Asacol/Mezavant)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age 18 years or more * Diagnosed ulcerative colitis * Signs of clinical activity with SCCAI of 3 or more * Extension more than 10 cm and no more than 40 cm from anus

Exclusion criteria

* Rectal temperature more than 38 degrees Celcius * Diagnosed celiac disease or lactose intolerance * Unable to speak or understand Danish * Prior biologics or systemic steroids 4 weeks up to inclusion

Design outcomes

Primary

Measure	Time frame	Description
Fecal calprotectin reduction	4 weeks	Relative reduction in fecal calprotectin measured before and after 4 weeks

Secondary

Measure	Time frame	Description
Clinical activity index	4 weeks	Simple Clinical Colitis Index, range 0-20
Quality of life	4 weeks	Quality of life measured yb Short Health Scale (4 items ranged 0-10, total range 0-40)
Endoscopic Mayo score	4 weeks	Grade of inflammation (range 0-3) in rectum according to Mayo score, visually judged during endoscopy
Serial fecal calprotectin	8 weeks	fecal calprotectin week 0-4-6-8

Countries

Denmark

Outcome results

None listed

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