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

• ClinicalTrials.gov Identifier: NCT01379183
• Recruitment Status: Completed
• First Posted: June 23, 2011
• Results First Posted: January 27, 2014
• Last Update Posted: March 21, 2016
• Sponsor: Mayo Clinic
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Information provided by (Responsible Party): Jeff Fidler, Mayo Clinic

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: Erythromycin; Drug: Placebo; Procedure: Magnetic Resonance Imaging; Other: Barium Sulfate Solution	Phase 2; Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Supportive Care
• Official Title: Magnetic Resonance (MR) Evaluation of the Effect of Erythromycin Upon Gastric and Small Bowel Motility
• Study Start Date: June 2011
• Actual Primary Completion Date: March 2012
• Actual Study Completion Date: March 2012

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Erythromycin; Erythromycin 200 mg i.v. suspension, Barium Sulfate Solution, and Magnetic Resonance Imaging	Drug: Erythromycin; 200 mg suspension; Other Name: Erythromycin suspension; Procedure: Magnetic Resonance Imaging; An MR enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel.; Other Names: MRI; Magnetic Resonance Enterography; Other: Barium 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.; Other Name: VoLumen
Placebo Comparator: Placebo; Matching placebo i.v. suspension, Barium Sulfate Solution, and Magnetic Resonance Imaging	Drug: Placebo; 200 mg suspension; Other Name: Water in 0.9% Sodium Chloride; Procedure: Magnetic Resonance Imaging; An MR enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel.; Other Names: MRI; Magnetic Resonance Enterography; Other: Barium 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.; Other Name: VoLumen

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Minnesota

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

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

Investigators

• Principal Investigator: Jeff Fidler, MD; Mayo Clinic

More Information

• Responsible Party: Jeff Fidler, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT01379183
• Other Study ID Numbers: 10-004869; P01DK068055 ( U.S. NIH Grant/Contract )
• First Posted: June 23, 2011
• Results First Posted: January 27, 2014
• Last Update Posted: March 21, 2016
• Last Verified: February 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Jeff Fidler, Mayo Clinic:

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

Additional relevant MeSH terms:

Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate; Anti-Bacterial Agents; Anti-Infective Agents; Gastrointestinal Agents; Protein Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action