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

Study 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.

Official Title
-----------------
Magnetic Resonance (MR) Evaluation of the Effect of Erythromycin Upon Gastric and Small Bowel Motility

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Erythromycin
* Drug: Placebo
* Procedure: Magnetic Resonance Imaging
* Other: Barium Sulfate Solution


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Erythromycin<br>Erythromycin 200 mg i.v. suspension, Barium Sulfate Solution, and Magnetic Resonance Imaging | Drug: Erythromycin<br>* 200 mg suspension<br>* Other names: Erythromycin suspension;Procedure: Magnetic Resonance Imaging<br>* An MR enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel.<br>* Other names: Magnetic Resonance Enterography;Other: Barium Sulfate Solution<br>* Participants will be given a low concentration of barium sulfate solution (1350 mL) prior to the MRI procedure. Barium sulfate is a radiopaque agent. Radiopaque agents are used to help diagnose certain medical problems. Since radiopaque agents are opaque to (block) x-rays, the areas of the body in which they are localized will appear white on the x-ray film. This creates the needed distinction, or contrast, between one organ and other tissues. The contrast will help the doctor see any special conditions that may exist in that organ or part of the body.<br>* Other names: VoLumen;|
| Placebo Comparator: Placebo<br>Matching placebo i.v. suspension, Barium Sulfate Solution, and Magnetic Resonance Imaging | Drug: Placebo<br>* 200 mg suspension<br>* Other names: Water in 0.9% Sodium Chloride;Procedure: Magnetic Resonance Imaging<br>* An MR enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel.<br>* Other names: Magnetic Resonance Enterography;Other: Barium Sulfate Solution<br>* Participants will be given a low concentration of barium sulfate solution (1350 mL) prior to the MRI procedure. Barium sulfate is a radiopaque agent. Radiopaque agents are used to help diagnose certain medical problems. Since radiopaque agents are opaque to (block) x-rays, the areas of the body in which they are localized will appear white on the x-ray film. This creates the needed distinction, or contrast, between one organ and other tissues. The contrast will help the doctor see any special conditions that may exist in that organ or part of the body.<br>* Other names: VoLumen;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric 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. | Approximately 60 minutes after beginning ingestion of fluid volume | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Jejunal 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. | Approximately 60 minutes after beginning ingestion of fluid volume | 
| Ileal 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. | Approximately 60 minutes after beginning ingestion of fluid volume | 
| Colonic 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. | Approximately 60 minutes after beginning ingestion of fluid volume | 
| Small Intestine 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. | Approximately 60 minutes after beginning ingestion of fluid volume | 
| Small Intestine and Colon 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. | Approximately 60 minutes after beginning ingestion of fluid volume | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy, Men, Women, No known gastrointestinal disease, Aged between 18-70 years