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Casein Glycomacropeptide in Active Distal Ulcerative Colitis (Pilot Study)

NCT01534312 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2016-11-22

No results posted yet for this study

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.

Conditions

  • Colitis, Ulcerative
  • Inflammatory Bowel Diseases

Interventions

DRUG

CGMP protein

Casein glycomacropeptide purified powder dissolved in 300 ML water once daily

DRUG

Maximal oral 5ASA

4800 grams/day of Mesalazine (Asacol/Mezavant)

Sponsors & Collaborators

  • Arla Foods

    collaborator INDUSTRY

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Hendrik Vilstrup, Professor · Professor, University of Aarhus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-09-30
Completion
2014-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01534312 on ClinicalTrials.gov