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| ID | Type | Description | Link |
|---|---|---|---|
| P01DK068055 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erythromycin | Active Comparator | Erythromycin 200 mg i.v. suspension, Barium Sulfate Solution, and Magnetic Resonance Imaging |
|
| Placebo | Placebo Comparator | Matching placebo i.v. suspension, Barium Sulfate Solution, and Magnetic Resonance Imaging |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erythromycin | Drug | 200 mg suspension |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Jejunal 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeff Fidler, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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There was no wash out or run-in period following participant enrollment.
Recruitment period: 07/09/2011 - 03/13/2013 Location: Mayo Clinic, Rochester, Minnesota
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| ID | Title | Description |
|---|---|---|
| FG000 | Erythromycin | Erythromycin 200 mg i.v. suspension |
| FG001 | Placebo | Matching placebo i.v. suspension |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Erythromycin | Erythromycin 200 mg i.v. suspension |
| BG001 | Placebo | Matching placebo i.v. suspension |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | mL | Approximately 60 minutes after beginning ingestion of fluid volume |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Erythromycin | Erythromycin 200 mg i.v. suspension |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeff L. Fidler | Mayo Clinic | 507-284-5010 | fidler.jeff@mayo.edu |
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| ID | Term |
|---|---|
| D018761 | Multiple Endocrine Neoplasia Type 1 |
| ID | Term |
|---|---|
| D009377 | Multiple Endocrine Neoplasia |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D014867 | Water |
| D012965 | Sodium Chloride |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Placebo | Drug | 200 mg suspension |
|
|
| Magnetic Resonance Imaging | Procedure | An MR enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. |
|
|
| 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. |
|
|
| Approximately 60 minutes after beginning ingestion of fluid volume |
| Ileal 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. | Approximately 60 minutes after beginning ingestion of fluid volume |
| Colonic 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. | Approximately 60 minutes after beginning ingestion of fluid volume |
| Small Intestine 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. | Approximately 60 minutes after beginning ingestion of fluid volume |
| Small Intestine and Colon 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. | Approximately 60 minutes after beginning ingestion of fluid volume |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Jejunal 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. | Posted | Mean | Standard Error | mL | Approximately 60 minutes after beginning ingestion of fluid volume |
|
|
|
|
| Secondary | Ileal 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. | Posted | Mean | Standard Error | mL | Approximately 60 minutes after beginning ingestion of fluid volume |
|
|
|
|
| Secondary | Colonic 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. | Posted | Mean | Standard Error | mL | Approximately 60 minutes after beginning ingestion of fluid volume |
|
|
|
|
| Secondary | Small Intestine 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. | Posted | Mean | Standard Error | mL | Approximately 60 minutes after beginning ingestion of fluid volume |
|
|
|
|
| Secondary | Small Intestine and Colon 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. | Posted | Mean | Standard Error | mL | Approximately 60 minutes after beginning ingestion of fluid volume |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Placebo | Matching placebo i.v. suspension | 0 | 20 | 0 | 20 |
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| D009378 |
| Neoplasms, Multiple Primary |
| D009386 | Neoplastic Syndromes, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004700 | Endocrine System Diseases |
| D006878 |
| Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D017670 | Sodium Compounds |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |