Therapeutic Modulation of the Intestinal Creatine Kinase System in Inflammatory Bowel Disease (IBD)
| Status: | Recruiting |
|---|---|
| Conditions: | Colitis, Irritable Bowel Syndrome (IBS), Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 2/23/2019 |
| Start Date: | April 2016 |
| End Date: | December 2019 |
| Contact: | Sandra Boimbo, MPH |
| Email: | sandra.boimbo@ucdenver.edu |
| Phone: | 3037248892 |
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.
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.
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.
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