Magnetic Resonance (MR) Evaluation of the Effect of Erythromycin Upon Gastric and Small Bowel Motility
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Gastric Volume
研究概览
简要总结
Magnetic Resonance Imaging (MRI) has proven to be a valuable imaging technique for suspected small bowel disease. This technique depends, in part, on adequate distension of the small bowel. This is accomplished by administering large volumes of a non-absorbable oral contrast material prior to the examination, which typically produces excellent distension of the distal small bowel and stomach, but poor distension of the proximal small bowel. Erythromycin is a common antibiotic that is known to promote stomach emptying and is used to treat diabetics with gastroparesis (poor stomach emptying.) The hypothesis of this study was that erythromycin will increase gastric emptying and hence improve small and large intestinal distention during MRI.
详细描述
Gastric, small, and large intestinal volumes were assessed with MRI after ingestion of a low concentration of barium sulfate solution (1350 mL) and randomization to erythromycin 200 mg i.v.) or placebo in 40 healthy volunteers. Magnetic Resonance Images of the abdomen were acquired with a torso phased array coil and a 1.5 tesla magnet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •Normal healthy adult volunteers without known gastrointestinal disease
- •Aged 18-70 years
- •Able to provide written informed consent before participating in the study
- •Able to communicate adequately with the investigator and to comply with the requirements for the entire study.
排除标准
- •Known allergy to erythromycin;
- •Use of drugs that have known contraindication with erythromycin (concomitant therapy with astemizole, cisapride, pimozide, or terfenadine)
- •Corrected QT interval on EKG >460 msec
- •Certain medications (i.e., theophylline, digoxin, oral anti-coagulant, benzodiazepine, 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors) will either be excluded from the study or, if medically safe, will be asked to discontinue the medication for 4 half-lives before beginning the study.
- •Use of medications that alter GI motility e.g., narcotics, medications with significant anticholinergic effects
- •Pregnant or breast-feeding females
- •Known claustrophobia
- •Known family history of sudden death or congenital QT prolongation
- •Presence of pacemaker, internal defibrillator, or other non-MR compatible device
- •Patients with known metal present within their abdomen
研究组 & 干预措施
Erythromycin
Erythromycin 200 mg i.v. suspension, Barium Sulfate Solution, and Magnetic Resonance Imaging
干预措施: Erythromycin (Drug)
Erythromycin
Erythromycin 200 mg i.v. suspension, Barium Sulfate Solution, and Magnetic Resonance Imaging
干预措施: Magnetic Resonance Imaging (Procedure)
Erythromycin
Erythromycin 200 mg i.v. suspension, Barium Sulfate Solution, and Magnetic Resonance Imaging
干预措施: Barium Sulfate Solution (Other)
Placebo
Matching placebo i.v. suspension, Barium Sulfate Solution, and Magnetic Resonance Imaging
干预措施: Placebo (Drug)
Placebo
Matching placebo i.v. suspension, Barium Sulfate Solution, and Magnetic Resonance Imaging
干预措施: Magnetic Resonance Imaging (Procedure)
Placebo
Matching placebo i.v. suspension, Barium Sulfate Solution, and Magnetic Resonance Imaging
干预措施: Barium Sulfate Solution (Other)
结局指标
主要结局
Gastric Volume
时间窗: Approximately 60 minutes after beginning ingestion of fluid volume
A Magnetic Resonance (MR) enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. MR images of the abdomen were acquired with a torso phased array coil and a 1.5 tesla magnet MRI. Gastric volumes were assessed with an axial 3D axial gradient echo sequence, which imaged the entire stomach in 13 seconds.
次要结局
- Jejunal Volume(Approximately 60 minutes after beginning ingestion of fluid volume)
- Ileal Volume(Approximately 60 minutes after beginning ingestion of fluid volume)
- Colonic Volume(Approximately 60 minutes after beginning ingestion of fluid volume)
- Small Intestine Volume(Approximately 60 minutes after beginning ingestion of fluid volume)
- Small Intestine and Colon Volume(Approximately 60 minutes after beginning ingestion of fluid volume)