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NCT01379183 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2, PHASE3
Status at capture
COMPLETED
Registry last update
2016-03-21

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Gastric Volume

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outcome · POSTED

Jejunal Volume

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outcome · POSTED

Ileal Volume

→

outcome · POSTED

Colonic Volume

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outcome · POSTED

Small Intestine Volume

→

outcome · POSTED

Small Intestine and Colon Volume

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility 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
healthy Volunteers
true
maximum Age
70 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Erythromycin 200 mg i.v. suspension, Barium Sulfate Solution, and Magnetic Resonance Imaging
    intervention Names
    1. Drug: Erythromycin
    2. Procedure: Magnetic Resonance Imaging
    3. Other: Barium Sulfate Solution
    label
    Erythromycin
    type
    ACTIVE_COMPARATOR
  2. description
    Matching placebo i.v. suspension, Barium Sulfate Solution, and Magnetic Resonance Imaging
    intervention Names
    1. Drug: Placebo
    2. Procedure: Magnetic Resonance Imaging
    3. Other: Barium Sulfate Solution
    label
    Placebo
    type
    PLACEBO_COMPARATOR
interventions
  1. arm Group Labels
    1. Erythromycin
    description
    200 mg suspension
    name
    Erythromycin
    other Names
    1. Erythromycin suspension
    type
    DRUG
  2. arm Group Labels
    1. Placebo
    description
    200 mg suspension
    name
    Placebo
    other Names
    1. Water in 0.9% Sodium Chloride
    type
    DRUG
  3. arm Group Labels
    1. Erythromycin
    2. Placebo
    description
    An MR enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel.
    name
    Magnetic Resonance Imaging
    other Names
    1. MRI
    2. Magnetic Resonance Enterography
    type
    PROCEDURE
  4. arm Group Labels
    1. Erythromycin
    2. Placebo
    description
    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.
    name
    Barium Sulfate Solution
    other Names
    1. VoLumen
    type
    OTHER
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
TRIPLE
who Masked
  1. PARTICIPANT
  2. CARE_PROVIDER
  3. INVESTIGATOR
primary Purpose
SUPPORTIVE_CARE
Enrollment
count
40
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Gastric Volume
    time Frame
    Approximately 60 minutes after beginning ingestion of fluid volume
secondary Outcomes
  1. description
    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.
    measure
    Jejunal Volume
    time Frame
    Approximately 60 minutes after beginning ingestion of fluid volume
  2. description
    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.
    measure
    Ileal Volume
    time Frame
    Approximately 60 minutes after beginning ingestion of fluid volume
  3. description
    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.
    measure
    Colonic Volume
    time Frame
    Approximately 60 minutes after beginning ingestion of fluid volume
  4. description
    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.
    measure
    Small Intestine Volume
    time Frame
    Approximately 60 minutes after beginning ingestion of fluid volume
  5. description
    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.
    measure
    Small Intestine and Colon Volume
    time Frame
    Approximately 60 minutes after beginning ingestion of fluid volume
Full 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.
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.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
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      edge id
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      requested nct id
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      source record id
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      source file sha256
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      payload
      clinical indication matching status
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      end exclusive
      true
      id
      nct-edge-d42b9aa31e94277fbb06
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
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      occurrences
      1. context exact
        NCT01379183
        end
        11
        exact text
        NCT01379183
        start
        0
      offset unit
      unicode_code_points
      query cond
      Small Intestine Cancer
      query disease state id
      ds-small-intestine-cancer
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-small-intestine-cancer-000.json
      source file sha256
      69c40ed34b17434f684079ec5635264bc5ad292871a86b835704fc99fa9d8157
      source json pointer
      /studies/72/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      3eeff359acb338bcb584344339199cd9f75f4a6f18c8ebc2a5719e1809a52ea6

    Preserved source evidence · Not medical advice