Therapeutic Modulation of the Intestinal Creatine Kinase System in Inflammatory Bowel Disease (IBD)
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Improvement in endoscopic assessment of mucosal inflammation in ulcerative colitis.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≥
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Creatine monohydrate (Drug)
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.
干预措施: Placebo (Other)
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.
干预措施: Creatine monohydrate (Drug)
结局指标
主要结局
Improvement in endoscopic assessment of mucosal inflammation in ulcerative colitis.
时间窗: 8 weeks
As defined by the Mayo endoscopic score for ulcerative colitis.
次要结局
- Clinical response in ulcerative colitis disease activity.(8 weeks)
- Intestinal permeability(8 weeks)
- Patient symptom severity(8 weeks)
- Colonic inflammation(8 weeks)
- Creatine kinase modulation(8 weeks)
- Clinical remission of ulcerative colitis disease activity.(8 weeks)
- Creatine modulation(8 weeks)