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Completed

NCT Number: NCT01379183

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

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.

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Key information

Conditions

Healthy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine Gland Neoplasms Endocrine System Diseases Genetic Diseases, Inborn Multiple Endocrine Neoplasia Multiple Endocrine Neoplasia Type 1 Neoplasms Neoplasms by Site Neoplasms, Multiple Primary Neoplastic Syndromes, Hereditary

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erythromycin

Drug

200 mg suspension

Other names: Erythromycin suspension

Placebo

Drug

200 mg suspension

Other names: Water in 0.9% Sodium Chloride

Magnetic Resonance Imaging

Procedure

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

Other names: MRI, Magnetic Resonance Enterography

Barium Sulfate Solution

Other

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.

Other names: VoLumen

Primary outcomes

  1. Gastric Volume

    Time frame: 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 outcomes

  1. Jejunal Volume

    Time frame: 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.

  2. Ileal Volume

    Time frame: 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.

  3. Colonic Volume

    Time frame: 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.

  4. Small Intestine Volume

    Time frame: 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.

  5. Small Intestine and Colon Volume

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 23, 2011
Registry last updated
Mar 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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