Casein Glycomacropeptide in Active Distal Ulcerative Colitis (Pilot Study)

• Register: ClinicalTrials.gov
• Last refreshed on: 28 November 2016
• Main ID: NCT01534312
• Date of registration: 13/02/2012
• Prospective Registration: No
• Primary sponsor: University of Aarhus
• Public title: Casein Glycomacropeptide in Active Distal Ulcerative Colitis (Pilot Study)
• Scientific title: Casein Glycomacropeptide in Active Distal Ulcerative Colitis (Pilot Study)
• Date of first enrolment: January 2012
• Target sample size: 24
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01534312
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Denmark

Contacts

• Name: Hendrik Vilstrup, Professor
• Affiliation: Professor, University of Aarhus

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Colitis, Ulcerative

Inflammatory Bowel Diseases

Intervention(s)

Drug: Maximal oral 5ASA

Drug: CGMP protein

Primary Outcome(s)

Fecal calprotectin reduction [Time Frame: 4 weeks]

Secondary Outcome(s)

Clinical activity index [Time Frame: 4 weeks]

Quality of life [Time Frame: 4 weeks]

Serial fecal calprotectin [Time Frame: 8 weeks]

Endoscopic Mayo score [Time Frame: 4 weeks]

Secondary ID(s)

CGMP in UC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Arla Foods