Colitis, UlcerativeCAGLUCIMNCT02825914
CAsein GLycomacropeptide in Ulcerative Colitis - Anti-Inflammatory and Microbiome Modulating Effects (CAGLUCIM)
A study testing Casein glycomacropeptide (CGMP) 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?
- Casein glycomacropeptide (CGMP)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2016to 1 Oct 2019
- 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
- ulcerative colitis (verified by mucosal histology and endoscopy)
- Clinically active ulcerative colitis (SCCAI ≥ 3)
Who cannot join
- Endoscopically inactive disease (Endoscopic Mayo Score of 0)
- Lactose or milk protein intolerance
- Celiac disease
- Not able to understand or speak Danish.
- Pregnant or nursing.
- Growth of pathogenic bacteria in stool culture from 4 weeks before and until randomization (Salmonella, Campylobacter, Yersinia or Clostridium Difficile.)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of medicine V (Hepatology and Gastroenterology)
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. In a pilot study the investigators found, that orally administered CGMP seems to have a beneficial effect comparable to that of mesalazine in active distal ulcerative colitis.
The investigators wish to evaluate the effects in a larger group of patients with active ulcerative colitis by studying the clinical effects and assessing the anti-inflammatory and microbiome modulating properties.
- Conditions
- Colitis, Ulcerative, Inflammatory Bowel Diseases
- Being tested
- Casein glycomacropeptide (CGMP), Placebo
- Keywords
- glycopeptides, human microbiome, caseinomacropeptide, whey protein, 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.
Casein glycomacropeptide (CGMP)Dietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Casein glycomacropeptide (CGMP) | Active comparator | As add-on to the standard medical treatment of active ulcerative colitis the patients will receive a daily oral intake of CGMP-protein-shake during 12 weeks. Receives: Dietary Supplement: Casein glycomacropeptide (CGMP) |
| Placebo | Placebo comparator | As add-on to the standard medical treatment of active ulcerative colitis the patients will receive a daily oral intake of placebo-shake consisting of milk powder during 12 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopic remission
The number of patients in endoscopic remission/macroscopic mucosal healing (Endoscopic Mayo Score of 0)
Measured: 12 weeks
Clinical remission
The number of patients in clinical remission (SCCAI ≤ 2)
Measured: 12 weeks
Clinical Response
The number of patients with clinical response (reduction of SCCAI-score of at least 2 points)
Measured: 12 weeks
Fecal inflammatory marker
The number of patients with a fecal-calprotectin below 150 mg/kg
Measured: 12 weeks
Secondary outcomes (3)
Endoscopic response
The number of patients with endoscopic response (reduction of Endoscopic Mayo Score of at least 1point)
Measured: 12 weeks
Steroid-free remission
The number of patients in steroid-free remission (SCCAI ≤ 2)
Measured: 12 weeks
Clinical remission at follow-up
The number of patients in clinical remission (SCCAI ≤ 2)
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study start1 Sep 2016
- Primary completion1 Jul 2019
- Study completion1 Oct 2019
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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hendrik A Vilstrup, Professor, Study chair, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825914
- Sponsor's protocol ID
- CAGLUCIM2016
- Acronym
- CAGLUCIM
- Status last verified
- Apr 2020
- First submitted
- 30 Jun 2016
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAsein GLycomacropeptide in Ulcerative Colitis - Anti-Inflammatory and Microbiome Modulating Effects (CAGLUCIM)
- ClinicalTrials.gov ID
- NCT02825914
- Acronym / sponsor ID
- CAGLUCIM / CAGLUCIM2016
- Conditions
- Colitis, Ulcerative, Inflammatory Bowel Diseases
- Keywords
- glycopeptides, human microbiome, caseinomacropeptide, whey protein, dietary proteins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 7 Jul 2016 (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. In a pilot study the investigators found, that orally administered CGMP seems to have a beneficial effect comparable to that of mesalazine in active distal ulcerative colitis.
The investigators wish to evaluate the effects in a larger group of patients with active ulcerative colitis by studying the clinical effects and assessing the anti-inflammatory and microbiome modulating properties.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Casein glycomacropeptide (CGMP) | Active comparator | Dietary Supplement: Casein glycomacropeptide (CGMP)As add-on to the standard medical treatment of active ulcerative colitis the patients will receive a daily oral intake of CGMP-protein-shake during 12 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboAs add-on to the standard medical treatment of active ulcerative colitis the patients will receive a daily oral intake of placebo-shake consisting of milk powder during 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ulcerative colitis (verified by mucosal histology and endoscopy)
- Clinically active ulcerative colitis (SCCAI ≥ 3)
Key exclusion criteria (6 listed)
- Endoscopically inactive disease (Endoscopic Mayo Score of 0)
- Lactose or milk protein intolerance
- Celiac disease
- Not able to understand or speak Danish.
- Pregnant or nursing.
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 |
|---|---|---|
| Casein glycomacropeptide (CGMP) | Dietary supplement | Casein glycomacropeptide (CGMP) |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Endoscopic remission
Time frame: 12 weeks
The number of patients in endoscopic remission/macroscopic mucosal healing (Endoscopic Mayo Score of 0)
Clinical remission
Time frame: 12 weeks
The number of patients in clinical remission (SCCAI ≤ 2)
Clinical Response
Time frame: 12 weeks
The number of patients with clinical response (reduction of SCCAI-score of at least 2 points)
Fecal inflammatory marker
Time frame: 12 weeks
The number of patients with a fecal-calprotectin below 150 mg/kg
3 secondary outcomes
Endoscopic response
Time frame: 12 weeks
Steroid-free remission
Time frame: 12 weeks
Clinical remission at follow-up
Time frame: 26 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 7 Apr 2020.
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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 A Vilstrup, Professor study chair
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 Casein glycomacropeptide (CGMP) 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 2 inclusion and 6 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 7 Apr 2020. 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. Some participants in this study may receive a placebo. 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?
Endoscopic remission (time frame: 12 weeks). The study lists 4 primary outcomes in all. 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 7 Apr 2020.