Phase 3 N=40 Randomized Triple-blind Supportive Care

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

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT01379183 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2014

Primary outcome: Primary: Gastric Volume — 262; 718 mL — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Erythromycin (Drug); Placebo (Drug); Magnetic Resonance Imaging (Procedure); Barium Sulfate Solution (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: Mar 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Gastric Volume	262; 718	<0.0001 sig
SECONDARY Jejunal Volume	450; 359	0.27
SECONDARY Ileal Volume	248; 248	0.96
SECONDARY Colonic Volume	190; 180	0.71
SECONDARY Small Intestine Volume	698; 607	0.37
SECONDARY Small Intestine and Colon Volume	910; 781	0.12

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01379183). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.