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

Mayo Clinic

Status and phase: Completed; Phase 3; Phase 2

Conditions: Healthy

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01379183

10-004869

P01DK068055 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Erythromycin

Active Comparator group

Description:

Erythromycin 200 mg i.v. suspension, Barium Sulfate Solution, and Magnetic Resonance Imaging

Treatment:

Drug: Erythromycin

Other: Barium Sulfate Solution

Procedure: Magnetic Resonance Imaging

Placebo

Placebo Comparator group

Description:

Matching placebo i.v. suspension, Barium Sulfate Solution, and Magnetic Resonance Imaging

Treatment:

Drug: Placebo

Other: Barium Sulfate Solution

Procedure: Magnetic Resonance Imaging