NCT02463305

Therapeutic Modulation of the Intestinal Creatine Kinase System in Inflammatory Bowel Disease (IBD)

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colitis, Ulcerative

Interventions

Type	Name	Description
DRUG	Creatine monohydrate	21 grams creatine monohydrate total per day
OTHER	Placebo	7 grams of dextrose dissolved in 500mL water, taken three times daily

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-03-01
• Completion: 2023-03-01
• First posted: 2015-06-04
• Last updated: 2023-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study