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

NCT ID: NCT02463305

Last Updated: 2023-04-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-31
• Study Completion Date: 2023-03-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Creatine monohydrate

Intervention Type: DRUG

21 grams creatine monohydrate total per day

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

7 grams of dextrose dissolved in 500mL water, taken three times daily

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.

Group Type: EXPERIMENTAL

Creatine monohydrate

Intervention Type: DRUG

21 grams creatine monohydrate total per day

Interventions

Creatine monohydrate

21 grams creatine monohydrate total per day

Intervention Type: DRUG

Placebo

7 grams of dextrose dissolved in 500mL water, taken three times daily

Intervention Type: OTHER

Other Intervention Names

Dextrose

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Gerich, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado Denver, Division of Gastroenterology

Locations

University of Colorado Hospital

Denver, Colorado, United States

Countries

United States

Other Identifiers

UL1TR001082

Identifier Type: NIH

Identifier Source: secondary_id

View Link

13-3054

Identifier Type: -

Identifier Source: org_study_id