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Casein Glycomacropeptide in Active Distal Ulcerative Colitis (Pilot Study)

NCT ID: NCT01534312

Last Updated: 2016-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Colitis, Ulcerative Inflammatory Bowel Diseases

Keywords

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Glycopeptides Dietary proteins

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CGMP protein

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

Group Type EXPERIMENTAL

CGMP protein

Intervention Type DRUG

Casein glycomacropeptide purified powder dissolved in 300 ML water once daily

Standard oral 5ASA maximal dose

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

Group Type ACTIVE_COMPARATOR

Maximal oral 5ASA

Intervention Type DRUG

4800 grams/day of Mesalazine (Asacol/Mezavant)

Interventions

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CGMP protein

Casein glycomacropeptide purified powder dissolved in 300 ML water once daily

Intervention Type DRUG

Maximal oral 5ASA

4800 grams/day of Mesalazine (Asacol/Mezavant)

Intervention Type DRUG

Other Intervention Names

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Casein glycomacropeptide Asacol Mezavant Mesalazine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arla Foods

INDUSTRY

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hendrik Vilstrup, Professor

Role: STUDY_CHAIR

Professor, University of Aarhus

Locations

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Department of medicine V (Hepatology and Gastroenterology)

Aarhus C, Aarhus C, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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CGMP in UC

Identifier Type: -

Identifier Source: org_study_id