Casein Glycomacropeptide in Active Distal Ulcerative Colitis (Pilot Study)

Inflammatory Bowel Diseases Clinical Trial

Official title:

Casein Glycomacropeptide in Active Distal Ulcerative Colitis (Pilot Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01534312
• Other study ID #: CGMP in UC
• Status: Completed
• Phase: N/A
• First received: February 13, 2012
• Last updated: November 20, 2016
• Start date: January 2012
• Est. completion date: December 2014

Study information

• Verified date: December 2012
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Inflammatory Bowel Diseases
• Ulcer

Intervention

Drug:
• CGMP protein
Casein glycomacropeptide purified powder dissolved in 300 ML water once daily
• Maximal oral 5ASA
4800 grams/day of Mesalazine (Asacol/Mezavant)

Locations

Country	Name	City	State
Denmark	Department of medicine V (Hepatology and Gastroenterology)	Aarhus C

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Arla Foods

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fecal calprotectin reduction	Relative reduction in fecal calprotectin measured before and after 4 weeks	4 weeks	No
Secondary	Clinical activity index	Simple Clinical Colitis Index, range 0-20	4 weeks	No
Secondary	Quality of life	Quality of life measured yb Short Health Scale (4 items ranged 0-10, total range 0-40)	4 weeks	No
Secondary	Endoscopic Mayo score	Grade of inflammation (range 0-3) in rectum according to Mayo score, visually judged during endoscopy	4 weeks	No
Secondary	Serial fecal calprotectin	fecal calprotectin week 0-4-6-8	8 weeks	No