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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01379183

Enrollment

Registered

2011-06-23

Start date

2011-06-30

Completion date

2012-03-31

Last updated

2016-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy, Men, Women, No known gastrointestinal disease, Aged between 18-70 years

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.

Interventions

DRUGErythromycin

200 mg suspension

DRUGPlacebo

200 mg suspension

PROCEDUREMagnetic Resonance Imaging

An MR enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel.

OTHERBarium Sulfate Solution

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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 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.

Countries

United States

Participant flow

Recruitment details

Recruitment period: 07/09/2011 - 03/13/2013 Location: Mayo Clinic, Rochester, Minnesota

Pre-assignment details

There was no wash out or run-in period following participant enrollment.

Participants by arm

Arm	Count
Erythromycin Erythromycin 200 mg i.v. suspension	19
Placebo Matching placebo i.v. suspension	21
Total	40

Baseline characteristics

Characteristic	Erythromycin	Placebo	Total
Age, Continuous	34 years STANDARD_DEVIATION 12.6	35 years STANDARD_DEVIATION 13	35 years STANDARD_DEVIATION 13
Region of Enrollment United States	19 participants	21 participants	40 participants
Sex: Female, Male Female	12 Participants	12 Participants	24 Participants
Sex: Female, Male Male	7 Participants	9 Participants	16 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 20	0 / 20
serious Total, serious adverse events	0 / 20	0 / 20

Outcome results

Primary

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.