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Trial record 1 of 6 for:    creatine IBD
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Therapeutic Modulation of the Intestinal Creatine Kinase System in Inflammatory Bowel Disease (IBD)

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ClinicalTrials.gov Identifier: NCT02463305
Recruitment Status : Recruiting
First Posted : June 4, 2015
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Colitis, Ulcerative Drug: Creatine monohydrate Other: Placebo Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Therapeutic Modulation of the Intestinal Creatine Kinase System in Inflammatory Bowel Disease (IBD)
Study Start Date : April 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment arm
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.
Drug: Creatine monohydrate
Placebo Comparator: Placebo arm
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.
Other: Placebo
Other Name: Dextrose

Experimental: Optional Open-Label Treatment arm
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.
Drug: Creatine monohydrate



Primary Outcome Measures :
  1. Improvement in endoscopic assessment of mucosal inflammation in ulcerative colitis. [ Time Frame: 8 weeks ]
    As defined by the Mayo endoscopic score for ulcerative colitis.


Secondary Outcome Measures :
  1. Clinical response in ulcerative colitis disease activity. [ Time Frame: 8 weeks ]
    As defined by the Mayo composite score for ulcerative colitis.

  2. Intestinal permeability [ Time Frame: 8 weeks ]
    As measured by urinary saccharide excretion

  3. Patient symptom severity [ Time Frame: 8 weeks ]
    As measured by inflammatory bowel disease questionnaire (IBDQ), simple Crohn's and colitis activity index (SCCAI), and Mayo composite scores.

  4. Colonic inflammation [ Time Frame: 8 weeks ]
    As assessed by fecal calprotectin, CRP, and histologic scoring.

  5. Creatine kinase modulation [ Time Frame: 8 weeks ]
    As assessed by CK transcript and protein in colonic tissue and serum levels.

  6. Clinical remission of ulcerative colitis disease activity. [ Time Frame: 8 weeks ]
    As defined by the Mayo composite score for ulcerative colitis.

  7. Creatine modulation [ Time Frame: 8 weeks ]
    As defined by colonic tissue and serum levels.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
    • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02463305


Contacts
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Contact: Sandra Boimbo, MPH 3037248892 sandra.boimbo@ucdenver.edu
Contact: Carlene Chun, MD, PhD 303-724-1857 carlene.chun@ucdenver.edu

Locations
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United States, Colorado
University of Colorado Hospital Recruiting
Denver, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Mark Gerich, MD University of Colorado Denver, Division of Gastroenterology
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02463305    
Other Study ID Numbers: 13-3054
UL1TR001082 ( U.S. NIH Grant/Contract )
First Posted: June 4, 2015    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Colorado, Denver:
Colitis, ulcerative
Inflammatory bowel diseases
Additional relevant MeSH terms:
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Colitis
Intestinal Diseases
Inflammatory Bowel Diseases
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes