Casein Glycomacropeptide in Active Distal Ulcerative Colitis (Pilot Study)

University of Aarhus24 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colitis, Ulcerative Inflammatory Bowel Diseases

Interventions

CGMP proteinDRUG

Casein glycomacropeptide purified powder dissolved in 300 ML water once daily

Maximal oral 5ASADRUG

4800 grams/day of Mesalazine (Asacol/Mezavant)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of medicine V (Hepatology and Gastroenterology)

Aarhus C, Aarhus C, Denmark

Outcomes

Primary Outcomes

Fecal calprotectin reduction

Relative reduction in fecal calprotectin measured before and after 4 weeks

Time frame: 4 weeks

Secondary Outcomes

Clinical activity index

Simple Clinical Colitis Index, range 0-20

Time frame: 4 weeks

Quality of life

Quality of life measured yb Short Health Scale (4 items ranged 0-10, total range 0-40)

Time frame: 4 weeks

Endoscopic Mayo score

Grade of inflammation (range 0-3) in rectum according to Mayo score, visually judged during endoscopy

Time frame: 4 weeks

Serial fecal calprotectin

fecal calprotectin week 0-4-6-8

Time frame: 8 weeks

Data from ClinicalTrials.gov

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