Targeting FMO-Mediated TMAO Formation in Kidney Disease (TMAO) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- TMAO
研究概览
简要总结
The project will investigate the modulation of flavin-containing monooxygenase (FMO) formation of the CVD risk factor trimethylamine-N-oxide (TMAO) in patients with kidney disease.
详细描述
Twelve patients with stage 3 to 4 kidney disease will receive an intervention for four weeks and a matching placebo in a crossover study design. Reduction of serum TMAO from baseline to end of intervention will be the primary endpoint.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects 18 years of age, but not more than 75 years of age at the time of enrollment.
- •Must be able to provide signed and dated informed consent.
- •Medical diagnosis of chronic kidney disease (eGFR ≤ 60 ml/min/1.73m2 )
排除标准
- •Vital signs outside of acceptable range at Screening Visit
- •Use of any of the following drugs within the last 3 months:
- •Systemic antibiotics, antifungals, antivirals or antiparasitics (intravenous, intramuscular, or oral); oral, intravenous, intramuscular, nasal or inhaled corticosteroids; cytokines; methotrexate or immunosuppressive cytotoxic agents; anti-diarrheal agents, bile acid sequestrants.
- •Consuming commercial probiotics including tablets, capsules, lozenges, chewing gum or powders in which probiotic is a primary component. Ordinary dietary components such as fermented beverages/milks, yogurts, foods do not apply.
- •Chronic, clinically significant hepatic abnormality (i.e. elevated 3X ULN ALT/AST), as determined by medical history or physical examination.
- •History of cancer except for squamous or basal cell carcinomas of the skin that have been medically managed by local excision.
- •Unstable dietary history as defined by major changes in diet during the previous month, where the subject has eliminated or significantly increased a major food group in the diet.
- •Recent history of chronic alcohol consumption defined as more than five 1.5-ounce servings of 80 proof distilled spirits, five 12-ounce servings of beer or five 5-ounce servings of wine per day.
- •Any confirmed or suspected condition/state of immunosuppression or immunodeficiency.
- •History of active uncontrolled gastrointestinal disorders or diseases including: Inflammatory bowel disease (IBD) including ulcerative colitis (mild-moderate-severe), Crohn's disease (mild-moderate-severe), or indeterminate colitis; irritable bowel syndrome (IBS) (moderate-severe); persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, Clostridium difficile infection (recurrent) or Helicobacter pylori infection (untreated); chronic constipation. Major surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years. Any major bowel resection at any time.
- •Patient who may be pregnant or lactating.
- •Not willing to abstain from cruciferous vegetable (i.e. cabbage, brussels sprouts, garden cress, mustard greens, turnips, broccoli, collard greens , cauliflower, kale) consumption.
- •Current smoking.
- •Unwilling or unable to adhere to study procedures or instructions.
- •Patients taking any of the following medications, methimazole, alosetron, duloxetine, ramelteon, tasimelteon, theophylline, tizanidine, clozapine, pirfenidone and ramosetron.
- •Allergies to corn or soy.
研究组 & 干预措施
Placebo
This crossover design will include 4 weeks of diindolylmethane and 4 weeks of matching placebo assignment.
干预措施: Commercially available Diindolylmethane (Dietary Supplement)
Placebo
This crossover design will include 4 weeks of diindolylmethane and 4 weeks of matching placebo assignment.
干预措施: Placebo (Other)
Commercially available Diindolylmethane
This crossover design will include 4 weeks of diindolylmethane and 4 weeks of matching placebo assignment.
干预措施: Commercially available Diindolylmethane (Dietary Supplement)
Commercially available Diindolylmethane
This crossover design will include 4 weeks of diindolylmethane and 4 weeks of matching placebo assignment.
干预措施: Placebo (Other)
结局指标
主要结局
TMAO
时间窗: 12 weeks.
Serum TMAO concentrations
次要结局
未报告次要终点
研究者
Thomas Nolin
Associate Professor
University of Pittsburgh