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Supplement

Creatine monohydrate for Ulcerative Colitis

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

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 more

Side effects data

From 2015 Phase 4 trial • 14 Patients • NCT01514630

71%

Cold and flu symptoms

29%

Diarrhea

21%

Stomach Discomfort

14%

Muscle Cramps

Lightheaded

Indigestion

Polydipsia

Headache

Swelling in Hands

Numbness and Tingling in hands

Nausea

100%

80%

60%

40%

20%

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

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