NCT01534312

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 13, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 16, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

November 22, 2016

Status Verified

December 1, 2012

Enrollment Period

2.7 years

First QC Date

February 13, 2012

Last Update Submit

November 20, 2016

Conditions

Colitis, UlcerativeInflammatory Bowel Diseases

Keywords

GlycopeptidesDietary proteins

Outcome Measures

Primary Outcomes (1)

  • Fecal calprotectin reduction

    Relative reduction in fecal calprotectin measured before and after 4 weeks

    4 weeks

Secondary Outcomes (4)

  • Clinical activity index

    4 weeks

  • Quality of life

    4 weeks

  • Endoscopic Mayo score

    4 weeks

  • Serial fecal calprotectin

    8 weeks

Study Arms (2)

CGMP protein

EXPERIMENTAL

Casein glycomacropeptide 30 gram/day, unchanged prophylactic 5ASA dose

Drug: CGMP protein

Standard oral 5ASA maximal dose

ACTIVE COMPARATOR

Increase from prophylactic dose 5ASA (mesalazine) to maximal oral dose, i.e. 4800 grams of mesalazine (Asacol/Mezavant)

Drug: Maximal oral 5ASA

Interventions

CGMP proteinDRUG

Casein glycomacropeptide purified powder dissolved in 300 ML water once daily

Also known as: Casein glycomacropeptide
CGMP protein
Maximal oral 5ASADRUG

4800 grams/day of Mesalazine (Asacol/Mezavant)

Also known as: Asacol, Mezavant, Mesalazine
Standard oral 5ASA maximal dose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Rectal temperature more than 38 degrees Celcius
  • Diagnosed celiac disease or lactose intolerance
  • Unable to speak or understand Danish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of medicine V (Hepatology and Gastroenterology)

Aarhus C, Aarhus C, 8000, Denmark

Location

MeSH Terms

Conditions

Colitis, UlcerativeInflammatory Bowel Diseases

Interventions

Mesalamine

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

meta-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsAminosalicylic AcidsSalicylatesHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenols

Study Officials

  • Hendrik Vilstrup, Professor

    Professor, University of Aarhus

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2012

First Posted

February 16, 2012

Study Start

January 1, 2012

Primary Completion

September 1, 2014

Study Completion

December 1, 2014

Last Updated

November 22, 2016

Record last verified: 2012-12

Locations

DK(1)