Using Magnetic Resonance (MR) to Understand the Effect of Erythromycin on Bowel Motility

Phase 2

Completed

Conditions: Healthy

Interventions: Drug: Erythromycin
Drug: Placebo
Procedure: Magnetic Resonance Imaging
Other: Barium Sulfate Solution

Registration Number: NCT01379183

Lead Sponsor: Mayo Clinic

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erythromycin	Erythromycin	Erythromycin 200 mg i.v. suspension, Barium Sulfate Solution, and Magnetic Resonance Imaging
Erythromycin	Magnetic Resonance Imaging	Erythromycin 200 mg i.v. suspension, Barium Sulfate Solution, and Magnetic Resonance Imaging
Erythromycin	Barium Sulfate Solution	Erythromycin 200 mg i.v. suspension, Barium Sulfate Solution, and Magnetic Resonance Imaging
Placebo	Placebo	Matching placebo i.v. suspension, Barium Sulfate Solution, and Magnetic Resonance Imaging
Placebo	Magnetic Resonance Imaging	Matching placebo i.v. suspension, Barium Sulfate Solution, and Magnetic Resonance Imaging
Placebo	Barium Sulfate Solution	Matching placebo i.v. suspension, Barium Sulfate Solution, and Magnetic Resonance Imaging

Primary Outcome Measures

Name	Time	Method
Gastric Volume	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 Outcome Measures

Name	Time	Method
Jejunal Volume	Approximately 60 minutes after beginning ingestion of fluid volume	The jejunum is the section of the small intestine between the duodenum and the ileum. A Magnetic Resonance (MR) enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. Small bowel volumes were evaluated with 5 mm thick coronal slices using a fat-suppressed true fast imaging with steady state precession sequence while the participant held his or her breath.
Ileal Volume	Approximately 60 minutes after beginning ingestion of fluid volume	The Ileal is the terminal portion of the small intestine extending from the jejunum to the cecum. A Magnetic Resonance (MR) enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. Small bowel volumes were evaluated with 5 mm thick coronal slices using a fat-suppressed true fast imaging with steady state precession sequence while the participant held his or her breath.
Colonic Volume	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. Small bowel volumes were evaluated with 5 mm thick coronal slices using a fat-suppressed true fast imaging with steady state precession sequence while the participant held his or her breath.
Small Intestine Volume	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. Small bowel volumes were evaluated with 5 mm thick coronal slices using a fat-suppressed true fast imaging with steady state precession sequence while the participant held his or her breath.
Small Intestine and Colon Volume	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. Small bowel volumes were evaluated with 5 mm thick coronal slices using a fat-suppressed true fast imaging with steady state precession sequence while the participant held his or her breath.