Magnetic Resonance (MR) Evaluation of the Effect of Erythromycin Upon Gastric and Small Bowel Motility
Overview
- Phase
- Phase 2
- Intervention
- Erythromycin
- Conditions
- Healthy
- Sponsor
- Mayo Clinic
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Gastric Volume
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Jeff Fidler
Principal Investigator
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
Erythromycin
Erythromycin 200 mg i.v. suspension, Barium Sulfate Solution, and Magnetic Resonance Imaging
Intervention: Erythromycin
Erythromycin
Erythromycin 200 mg i.v. suspension, Barium Sulfate Solution, and Magnetic Resonance Imaging
Intervention: Magnetic Resonance Imaging
Erythromycin
Erythromycin 200 mg i.v. suspension, Barium Sulfate Solution, and Magnetic Resonance Imaging
Intervention: Barium Sulfate Solution
Placebo
Matching placebo i.v. suspension, Barium Sulfate Solution, and Magnetic Resonance Imaging
Intervention: Placebo
Placebo
Matching placebo i.v. suspension, Barium Sulfate Solution, and Magnetic Resonance Imaging
Intervention: Magnetic Resonance Imaging
Placebo
Matching placebo i.v. suspension, Barium Sulfate Solution, and Magnetic Resonance Imaging
Intervention: Barium Sulfate Solution
Outcomes
Primary Outcomes
Gastric Volume
Time Frame: 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.
Secondary Outcomes
- 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)