Casein Glycomacropeptide in Active Distal Ulcerative Colitis (Pilot Study)

Not Applicable

Completed

• Conditions: Colitis, Ulcerative; Inflammatory Bowel Diseases
• Interventions: Drug: CGMP protein; Drug: Maximal oral 5ASA

• Registration Number: NCT01534312
• Lead Sponsor: University of Aarhus

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-02-13
• Study First Submitted QC: 2012-02-13
• Study First Posted: 2012-02-16
• Status Verified: 2012-12
• Primary Completion: 2014-09
• Study Completion: 2014-12
• Last Update Submitted: 2016-11-20
• Last Update Posted: 2016-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CGMP protein	CGMP protein	Casein glycomacropeptide 30 gram/day, unchanged prophylactic 5ASA dose
Standard oral 5ASA maximal dose	Maximal oral 5ASA	Increase from prophylactic dose 5ASA (mesalazine) to maximal oral dose, i.e. 4800 grams of mesalazine (Asacol/Mezavant)

Primary Outcome Measures

Name	Time	Method
Fecal calprotectin reduction	4 weeks	Relative reduction in fecal calprotectin measured before and after 4 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of medicine V (Hepatology and Gastroenterology); 🇩🇰 Aarhus C, Denmark