Clinical trial NCT01379183: Using Magnetic Resonance (MR) to Understand the Effect of Erythromycin on Bowel Motility
Official title: Magnetic Resonance (MR) Evaluation of the Effect of Erythromycin Upon Gastric and Small Bowel Motility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Healthy
Keywords: Healthy
Men
Women
No known gastrointestinal disease
Aged between 18-70 years
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2011-06-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Gastric Volume
timeFrame: Approximately 60 minutes after beginning ingestion of fluid volume
Secondary outcomes:
measure: Jejunal Volume
timeFrame: Approximately 60 minutes after beginning ingestion of fluid volume
measure: Ileal Volume
timeFrame: Approximately 60 minutes after beginning ingestion of fluid volume
measure: Colonic Volume
timeFrame: Approximately 60 minutes after beginning ingestion of fluid volume
measure: Small Intestine Volume
timeFrame: Approximately 60 minutes after beginning ingestion of fluid volume
measure: Small Intestine and Colon Volume
timeFrame: Approximately 60 minutes after beginning ingestion of fluid volume
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Jeff Fidler, MD
role: PRINCIPAL_INVESTIGATOR
References: