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Supplement
Therapeutic Modulation of the Intestinal Creatine Kinase System in Inflammatory Bowel Disease (IBD)
Phase < 1
Waitlist Available
Led By Mark Gerich, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Summary
This trial studies how creatine monohydrate affects ulcerative colitis. Creatine provides energy to colon cells, helping them form a tight barrier that may reduce inflammation. Creatine is critical for maintaining intestinal health under inflammatory stress.
Eligible Conditions
- Ulcerative Colitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Ulcerative Colitis
Secondary study objectives
Clinical remission of ulcerative colitis disease activity.
Clinical response in ulcerative colitis disease activity.
Colonic inflammation
+4 moreSide effects data
From 2015 Phase 4 trial • 14 Patients • NCT0151463071%
Cold and flu symptoms
29%
Diarrhea
21%
Stomach Discomfort
14%
Muscle Cramps
7%
Lightheaded
7%
Indigestion
7%
Polydipsia
7%
Headache
7%
Swelling in Hands
7%
Numbness and Tingling in hands
7%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Creatine Monohydrate
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment armExperimental Treatment1 Intervention
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.
Group II: Optional Open-Label Treatment armExperimental Treatment1 Intervention
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.
Group III: Placebo armPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Creatine monohydrate
2005
Completed Phase 4
~670
Find a Location
Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,810 Previous Clinical Trials
2,920,100 Total Patients Enrolled
2 Trials studying Ulcerative Colitis
72 Patients Enrolled for Ulcerative Colitis
Mark Gerich, MDPrincipal InvestigatorUniversity of Colorado Denver, Division of Gastroenterology