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

NCT01379183 | Completed Phase 2 Results

• 2 other identifiers: 10-004869P01DK068055
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Approximately 60 minutes after beginning ingestion of fluid volume

Secondary Outcomes (5)

• Jejunal Volume

  Approximately 60 minutes after beginning ingestion of fluid volume

• Ileal Volume

  Approximately 60 minutes after beginning ingestion of fluid volume

• Colonic Volume

  Approximately 60 minutes after beginning ingestion of fluid volume

• Small Intestine Volume

  Approximately 60 minutes after beginning ingestion of fluid volume

• Small Intestine and Colon Volume

  Approximately 60 minutes after beginning ingestion of fluid volume

Study Arms (2)

Erythromycin

ACTIVE COMPARATOR

Erythromycin 200 mg i.v. suspension, Barium Sulfate Solution, and Magnetic Resonance Imaging

Drug: Erythromycin; Procedure: Magnetic Resonance Imaging; Other: Barium Sulfate Solution

Placebo

PLACEBO COMPARATOR

Matching placebo i.v. suspension, Barium Sulfate Solution, and Magnetic Resonance Imaging

Drug: Placebo; Procedure: Magnetic Resonance Imaging; Other: Barium Sulfate Solution

Interventions

Erythromycin DRUG

200 mg suspension

Also known as: Erythromycin suspension

Erythromycin

Placebo DRUG

200 mg suspension

Also known as: Water in 0.9% Sodium Chloride

Placebo

Magnetic Resonance Imaging PROCEDURE

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

Also known as: MRI, Magnetic Resonance Enterography

Erythromycin; Placebo

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.

Also known as: VoLumen

Erythromycin; Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Multiple Endocrine Neoplasia Type 1

Interventions

Erythromycin; Water; Sodium Chloride; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Dr. Jeff L. Fidler
• Organization: Mayo Clinic

fidler.jeff@mayo.edu

507-284-5010

Study Officials

• Jeff Fidler, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 15, 2011
• First Posted: June 23, 2011
• Study Start: June 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: March 21, 2016
• Results First Posted: January 27, 2014

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)