Colitis, UlcerativeNCT01534312
Casein Glycomacropeptide in Active Distal Ulcerative Colitis (Pilot Study)
A study testing CGMP protein and Maximal oral 5ASA in people with Colitis, Ulcerative and Inflammatory Bowel Diseases, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colitis, Ulcerative, Inflammatory Bowel Diseases
- What is being tested?
- CGMP protein and Maximal oral 5ASA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of medicine V (Hepatology and Gastroenterology)
Aarhus C, Aarhus C, 8000
About this study
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.
Read the detailed 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.
- Conditions
- Colitis, Ulcerative, Inflammatory Bowel Diseases
- Being tested
- CGMP protein, Maximal oral 5ASA
- Keywords
- Glycopeptides, Dietary proteins
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGMP proteinDrug
Also called Casein glycomacropeptide
Casein glycomacropeptide purified powder dissolved in 300 ML water once daily
Maximal oral 5ASADrug
Also called Asacol, Mezavant, Mesalazine
4800 grams/day of Mesalazine (Asacol/Mezavant)
| Study group | Role | What they receive |
|---|---|---|
| CGMP protein | Experimental | Casein glycomacropeptide 30 gram/day, unchanged prophylactic 5ASA dose Receives: 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) Receives: Drug: Maximal oral 5ASA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal calprotectin reduction
Relative reduction in fecal calprotectin measured before and after 4 weeks
Measured: 4 weeks
Secondary outcomes (4)
Clinical activity index
Simple Clinical Colitis Index, range 0-20
Measured: 4 weeks
Quality of life
Quality of life measured yb Short Health Scale (4 items ranged 0-10, total range 0-40)
Measured: 4 weeks
Endoscopic Mayo score
Grade of inflammation (range 0-3) in rectum according to Mayo score, visually judged during endoscopy
Measured: 4 weeks
Serial fecal calprotectin
fecal calprotectin week 0-4-6-8
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionSep 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Arla Foods
- Responsible party
- Sponsor
- Investigators
- Hendrik Vilstrup, Professor, Study chair, Professor, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01534312
- Sponsor's protocol ID
- CGMP in UC
- Status last verified
- Dec 2012
- First submitted
- 13 Feb 2012
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Casein Glycomacropeptide in Active Distal Ulcerative Colitis (Pilot Study)
- ClinicalTrials.gov ID
- NCT01534312
- Acronym / sponsor ID
- CGMP in UC
- Conditions
- Colitis, Ulcerative, Inflammatory Bowel Diseases
- Keywords
- Glycopeptides, Dietary proteins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Arla Foods
- Study start
- Jan 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 16 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGMP protein | Experimental | Drug: CGMP proteinCasein glycomacropeptide 30 gram/day, unchanged prophylactic 5ASA dose |
| Standard oral 5ASA maximal dose | Active comparator | Drug: Maximal oral 5ASAIncrease from prophylactic dose 5ASA (mesalazine) to maximal oral dose, i.e. 4800 grams of mesalazine (Asacol/Mezavant) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CGMP proteinAlso: Casein glycomacropeptideCasein glycomacropeptide purified powder dissolved in 300 ML water once daily | Drug | CGMP protein |
| Maximal oral 5ASAAlso: Asacol, Mezavant, Mesalazine4800 grams/day of Mesalazine (Asacol/Mezavant) | Drug | Standard oral 5ASA maximal dose |
Primary outcome
Fecal calprotectin reduction
Time frame: 4 weeks
Relative reduction in fecal calprotectin measured before and after 4 weeks
4 secondary outcomes
Clinical activity index
Time frame: 4 weeks
Quality of life
Time frame: 4 weeks
Endoscopic Mayo score
Time frame: 4 weeks
Serial fecal calprotectin
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hendrik Vilstrup, Professor study chair
Professor, University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CGMP protein and Maximal oral 5ASA in people with Colitis, Ulcerative and Inflammatory Bowel Diseases, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal calprotectin reduction (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2016.