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
|Condition or disease||Intervention/treatment||Phase|
|Colitis, Ulcerative||Drug: Creatine monohydrate Other: Placebo||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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 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
- Improvement in endoscopic assessment of mucosal inflammation in ulcerative colitis. [ Time Frame: 8 weeks ]As defined by the Mayo endoscopic score for ulcerative colitis.
- 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.
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
|Contact: Sandra Boimbo, MPHemail@example.com|
|Contact: Carlene Chun, MD, PhDfirstname.lastname@example.org|
|United States, Colorado|
|University of Colorado Hospital||Recruiting|
|Denver, Colorado, United States, 80045|
|Principal Investigator:||Mark Gerich, MD||University of Colorado Denver, Division of Gastroenterology|