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

Colitis, Ulcerative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02463305
• Other study ID #: 13-3054
• Secondary ID: UL1TR001082
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: August 2022
• Est. completion date: March 1, 2023

Study information

• Verified date: April 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Drug:
• Creatine monohydrate
21 grams creatine monohydrate total per day

Other:
• Placebo
7 grams of dextrose dissolved in 500mL water, taken three times daily

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in endoscopic assessment of mucosal inflammation in ulcerative colitis.	As defined by the Mayo endoscopic score for ulcerative colitis.	8 weeks
Secondary	Clinical response in ulcerative colitis disease activity.	As defined by the Mayo composite score for ulcerative colitis.	8 weeks
Secondary	Intestinal permeability	As measured by urinary saccharide excretion	8 weeks
Secondary	Patient symptom severity	As measured by inflammatory bowel disease questionnaire (IBDQ), simple Crohn's and colitis activity index (SCCAI), and Mayo composite scores.	8 weeks
Secondary	Colonic inflammation	As assessed by fecal calprotectin, CRP, and histologic scoring.	8 weeks
Secondary	Creatine kinase modulation	As assessed by CK transcript and protein in colonic tissue and serum levels.	8 weeks
Secondary	Clinical remission of ulcerative colitis disease activity.	As defined by the Mayo composite score for ulcerative colitis.	8 weeks
Secondary	Creatine modulation	As defined by colonic tissue and serum levels.	8 weeks