Colitis, UlcerativeEarly Phase 1NCT02463305
Therapeutic Modulation of the Intestinal Creatine Kinase System in Inflammatory Bowel Disease (IBD)
A Early Phase 1 study testing Creatine monohydrate in people with Colitis, Ulcerative, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study plans to learn more about the effects that creatine monohydrate has on disease activity in ulcerative colitis. Creatine is a substance that is naturally produced by the body and is found in foods, such as meat and fish. Creatine helps to provide energy to some body tissues, such as the colon. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colitis, Ulcerative
- What is being tested?
- Creatine monohydrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2022to 1 Mar 2023
- Phase
- Early Phase 1
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged 18-70 years old with mild- to moderately-active UC that extends at least 15 cm proximal to the anal verge (i.e. not proctitis) as defined by a Mayo Score of 3-10, with an endoscopic subscore ≥ 1.
- Allowed concomitant medications will include mesalamine compounds if used for at least 8 weeks and at a stable dose for at least 4 weeks, as well as thiopurines (azathioprine, 6-mercaptopurine) if used at a stable dose for at least 3 months.
Who cannot join
- Abnormal baseline laboratory tests:
- Albumin < 3.0 g/dL
- ALT, AST, total bilirubin, or alkaline phosphatase > 1.5 x ULN
- Potassium < 3.0 mmol/L or > 5.5 mmol/L
- Creatinine or cystatin C > ULN
- WBC ≤ 3000
Show all 18Show fewer
- Platelets ≤ 105
- Hemoglobin ≤ 10g/dL
- Positive stool test for Clostridium difficile, ova and parasites, or routine stool culture
- Pregnancy (as confirmed by urine pregnancy test at study outset), stated desire to become pregnant during the study period, or refusal/inability to use effective methods of contraception during the study period.
- Concomitant major comorbidities (renal, hepatic, cardiac, pulmonary or malignancy) to include any medical conditions requiring therapeutic anti-coagulation or anti-platelet therapy.
- Diagnosis of severe UC (Mayo Score > 10)
- Evidence or history of toxic megacolon
- Patients who received anti-TNF agents within 3 months of screening, or who used oral or rectal corticosteroids within 4 weeks of screening will be excluded.
- Use of over-the-counter herbal or dietary supplements (excluding vitamin and minerals) two weeks prior to or during the study period.
- Use of known nephrotoxic medications (including non-steroidal anti-inflammatory drugs (NSAIDs), cyclosporin A, tacrolimus, aminoglycoside antibiotics, diuretics, angiotensin converting enzyme (ACE) inhibitors, or angiotensin receptor blockers) 2 weeks prior to or during the study period
- Prior surgical bowel resections (excluding appendectomy)
- Local or systemic complications or other pathological states requiring therapy with corticosteroids and/or immunosuppressive agents.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Denver, Colorado, 80045
About this study
This study plans to learn more about the effects that creatine monohydrate has on disease activity in ulcerative colitis. Creatine is a substance that is naturally produced by the body and is found in foods, such as meat and fish. Creatine helps to provide energy to some body tissues, such as the colon. In the colon, this energy allows cells to form a tight barrier between molecules in digested food and bacteria and the body's infection-fighting cells within the colon underneath this barrier. If the barrier becomes "leaky" molecules may pass through and lead to inflammation. This "leakiness" may contribute to the colon inflammation seen in ulcerative colitis.
- Conditions
- Colitis, Ulcerative
- Being tested
- Creatine monohydrate, Placebo
- Keywords
- Colitis, ulcerative, Inflammatory bowel diseases
- 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.
Creatine monohydrateDrug
21 grams creatine monohydrate total per day
PlaceboOther
Also called Dextrose
7 grams of dextrose dissolved in 500mL water, taken three times daily
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | 6 patients with mild-moderate ulcerative colitis treated with creatine monohydrate 21 grams per day in three divided doses taken with water for 8 weeks. Receives: Drug: Creatine monohydrate |
| Placebo arm | Placebo comparator | 6 patients with mild-moderate ulcerative colitis treated with placebo (matching creatine monohydrate) 21 grams per day in three divided doses taken with water for 8 weeks. Receives: Other: Placebo |
| Optional Open-Label Treatment arm | Experimental | Up to 6 patients, who were randomized to the placebo arm, will be given the option to continue with open-label creatine monohydrate treatment at 21 grams per day in three divided doses, taken with water, for 8 weeks. Only non-invasive testing will be performed. Receives: Drug: Creatine monohydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in endoscopic assessment of mucosal inflammation in ulcerative colitis.
As defined by the Mayo endoscopic score for ulcerative colitis.
Measured: 8 weeks
Secondary outcomes (7)
Clinical response in ulcerative colitis disease activity.
As defined by the Mayo composite score for ulcerative colitis.
Measured: 8 weeks
Intestinal permeability
As measured by urinary saccharide excretion
Measured: 8 weeks
Patient symptom severity
As measured by inflammatory bowel disease questionnaire (IBDQ), simple Crohn's and colitis activity index (SCCAI), and Mayo composite scores.
Measured: 8 weeks
Colonic inflammation
As assessed by fecal calprotectin, CRP, and histologic scoring.
Measured: 8 weeks
Creatine kinase modulation
As assessed by CK transcript and protein in colonic tissue and serum levels.
Measured: 8 weeks
Clinical remission of ulcerative colitis disease activity.
As defined by the Mayo composite score for ulcerative colitis.
Measured: 8 weeks
Creatine modulation
As defined by colonic tissue and serum levels.
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 posted4 Jun 2015 (estimated)
- Study startAug 2022 (estimated)
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Why it stopped: inability to enroll
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 Colorado, DenverThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Gerich, MD, Principal investigator, University of Colorado Denver, Division of Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02463305
- Sponsor's protocol ID
- 13-3054
- Other IDs
- UL1TR001082
- Status last verified
- Apr 2023
- First submitted
- 27 May 2015
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Modulation of the Intestinal Creatine Kinase System in Inflammatory Bowel Disease (IBD)
- ClinicalTrials.gov ID
- NCT02463305
- Acronym / sponsor ID
- 13-3054
- Conditions
- Colitis, Ulcerative
- Keywords
- Colitis, ulcerative, Inflammatory bowel diseases
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: inability to enroll
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Aug 2022 (estimated)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 4 Jun 2015 (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.
This study plans to learn more about the effects that creatine monohydrate has on disease activity in ulcerative colitis. Creatine is a substance that is naturally produced by the body and is found in foods, such as meat and fish. Creatine helps to provide energy to some body tissues, such as the colon. In the colon, this energy allows cells to form a tight barrier between molecules in digested food and bacteria and the body's infection-fighting cells within the colon underneath this barrier. If the barrier becomes "leaky" molecules may pass through and lead to inflammation. This "leakiness" may contribute to the colon inflammation seen in ulcerative colitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: Creatine monohydrate6 patients with mild-moderate ulcerative colitis treated with creatine monohydrate 21 grams per day in three divided doses taken with water for 8 weeks. |
| Placebo arm | Placebo comparator | Other: Placebo6 patients with mild-moderate ulcerative colitis treated with placebo (matching creatine monohydrate) 21 grams per day in three divided doses taken with water for 8 weeks. |
| Optional Open-Label Treatment arm | Experimental | Drug: Creatine monohydrateUp to 6 patients, who were randomized to the placebo arm, will be given the option to continue with open-label creatine monohydrate treatment at 21 grams per day in three divided doses, taken with water, for 8 weeks. Only non-invasive testing will be performed. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female patients aged 18-70 years old with mild- to moderately-active UC that extends at least 15 cm proximal to the anal verge (i.e. not proctitis) as defined by a Mayo Score of 3-10, with an endoscopic subscore ≥ 1.
- Allowed concomitant medications will include mesalamine compounds if used for at least 8 weeks and at a stable dose for at least 4 weeks, as well as thiopurines (azathioprine, 6-mercaptopurine) if used at a stable dose for at least 3 months.
Key exclusion criteria (18 listed)
- Abnormal baseline laboratory tests:
- Pregnancy (as confirmed by urine pregnancy test at study outset), stated desire to become pregnant during the study period, or refusal/inability to use effective methods of contraception during the study period.
- Concomitant major comorbidities (renal, hepatic, cardiac, pulmonary or malignancy) to include any medical conditions requiring therapeutic anti-coagulation or anti-platelet therapy.
- Diagnosis of severe UC (Mayo Score > 10)
- Evidence or history of toxic megacolon
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 |
|---|---|---|
| Creatine monohydrate21 grams creatine monohydrate total per day | Drug | Optional Open-Label Treatment arm, Treatment arm |
| PlaceboAlso: Dextrose7 grams of dextrose dissolved in 500mL water, taken three times daily | Other | Placebo arm |
Primary outcome
Improvement in endoscopic assessment of mucosal inflammation in ulcerative colitis.
Time frame: 8 weeks
As defined by the Mayo endoscopic score for ulcerative colitis.
7 secondary outcomes
Clinical response in ulcerative colitis disease activity.
Time frame: 8 weeks
Intestinal permeability
Time frame: 8 weeks
Patient symptom severity
Time frame: 8 weeks
Colonic inflammation
Time frame: 8 weeks
Creatine kinase modulation
Time frame: 8 weeks
Clinical remission of ulcerative colitis disease activity.
Time frame: 8 weeks
Creatine modulation
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Mark Gerich, MD principal investigator
University of Colorado Denver, Division of Gastroenterology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Creatine monohydrate in people with Colitis, Ulcerative, run by University of Colorado, Denver at 1 site in United States.
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 18 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: withdrawn, as of the sponsor's last update on 6 Apr 2023. 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 United States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Improvement in endoscopic assessment of mucosal inflammation in ulcerative colitis. (time frame: 8 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 6 Apr 2023.