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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Recruitment Status : Withdrawn (inability to enroll)
First Posted : June 4, 2015
Last Update Posted : April 6, 2023
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE May 27, 2015
First Posted Date  ICMJE June 4, 2015
Last Update Posted Date April 6, 2023
Estimated Study Start Date  ICMJE August 2022
Actual Primary Completion Date March 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2015)
Improvement in endoscopic assessment of mucosal inflammation in ulcerative colitis. [ Time Frame: 8 weeks ]
As defined by the Mayo endoscopic score for ulcerative colitis.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2017)
  • Clinical response in ulcerative colitis disease activity. [ Time Frame: 8 weeks ]
    As defined by the Mayo composite score for ulcerative colitis.
  • Intestinal permeability [ Time Frame: 8 weeks ]
    As measured by urinary saccharide excretion
  • 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.
  • Colonic inflammation [ Time Frame: 8 weeks ]
    As assessed by fecal calprotectin, CRP, and histologic scoring.
  • Creatine kinase modulation [ Time Frame: 8 weeks ]
    As assessed by CK transcript and protein in colonic tissue and serum levels.
  • Clinical remission of ulcerative colitis disease activity. [ Time Frame: 8 weeks ]
    As defined by the Mayo composite score for ulcerative colitis.
  • Creatine modulation [ Time Frame: 8 weeks ]
    As defined by colonic tissue and serum levels.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2015)
  • Clinical response in ulcerative colitis disease activity. [ Time Frame: 8 weeks ]
    As defined by the Mayo composite score for ulcerative colitis.
  • Intestinal permeability [ Time Frame: 8 weeks ]
    As measured by urinary saccharide excretion and serum lipopolysaccharide (LPS) level.
  • 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.
  • Colonic inflammation [ Time Frame: 8 weeks ]
    As assessed by fecal calprotectin, CRP, and histologic scoring.
  • Creatine kinase modulation [ Time Frame: 8 weeks ]
    As assessed by CK transcript and protein in colonic tissue and serum levels.
  • Clinical remission of ulcerative colitis disease activity. [ Time Frame: 8 weeks ]
    As defined by the Mayo composite score for ulcerative colitis.
  • Creatine modulation [ Time Frame: 8 weeks ]
    As defined by colonic tissue and serum levels.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Therapeutic Modulation of the Intestinal Creatine Kinase System in Inflammatory Bowel Disease (IBD)
Official Title  ICMJE Therapeutic Modulation of the Intestinal Creatine Kinase System in Inflammatory Bowel Disease (IBD)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Colitis, Ulcerative
Intervention  ICMJE
  • Drug: Creatine monohydrate
    21 grams creatine monohydrate total per day
  • Other: Placebo
    7 grams of dextrose dissolved in 500mL water, taken three times daily
    Other Name: Dextrose
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Other: Placebo
  • 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.
    Intervention: Drug: Creatine monohydrate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 3, 2023)
0
Original Estimated Enrollment  ICMJE
 (submitted: June 1, 2015)
6
Actual Study Completion Date  ICMJE March 1, 2023
Actual Primary Completion Date March 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02463305
Other Study ID Numbers  ICMJE 13-3054
UL1TR001082 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party University of Colorado, Denver
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Colorado, Denver
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mark Gerich, MD University of Colorado Denver, Division of Gastroenterology
PRS Account University of Colorado, Denver
Verification Date April 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP