HealthyPhase 2/3NCT01379183
Using Magnetic Resonance (MR) to Understand the Effect of Erythromycin on Bowel Motility
A Phase 2/3 study testing Erythromycin, Magnetic Resonance Imaging and Barium Sulfate Solution in people with Healthy, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Erythromycin, Magnetic Resonance Imaging and Barium Sulfate Solution
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Mar 2012
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Magnetic Resonance (MR) Evaluation of the Effect of Erythromycin Upon Gastric and Small 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Erythromycin, Placebo, Magnetic Resonance Imaging, Barium Sulfate Solution
- Keywords
- Healthy, Men, Women, No known gastrointestinal disease, Aged between 18-70 years
- Medical subject headings
- Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErythromycinDrug
Also called Erythromycin suspension
200 mg suspension
PlaceboDrug
Also called Water in 0.9% Sodium Chloride
200 mg suspension
Magnetic Resonance ImagingProcedure or surgery
Also called MRI, Magnetic Resonance Enterography
An MR enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel.
Barium Sulfate SolutionOther
Also called VoLumen
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.
| Study group | Role | What they receive |
|---|---|---|
| Erythromycin | Active comparator | Erythromycin 200 mg i.v. suspension, Barium Sulfate Solution, and Magnetic Resonance Imaging Receives: 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 Receives: Drug: Placebo; Procedure: Magnetic Resonance Imaging; Other: Barium Sulfate Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 60 minutes after beginning ingestion of fluid volume
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Approximately 60 minutes after beginning ingestion of fluid volume
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeff Fidler, Mayo Clinic
- Investigators
- Jeff Fidler, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01379183
- Sponsor's protocol ID
- 10-004869
- Other IDs
- P01DK068055
- Status last verified
- Feb 2016
- First submitted
- 15 Jun 2011
- Last updated
- 21 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance (MR) Evaluation of the Effect of Erythromycin Upon Gastric and Small Bowel Motility
- ClinicalTrials.gov ID
- NCT01379183
- Acronym / sponsor ID
- 10-004869
- Conditions
- Healthy
- Keywords
- Healthy, Men, Women, No known gastrointestinal disease, Aged between 18-70 years
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jun 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 23 Jun 2011 (estimated)
- Results
- Posted 27 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erythromycin | Active comparator | Drug: Erythromycin, Procedure: Magnetic Resonance Imaging, Other: Barium Sulfate SolutionErythromycin 200 mg i.v. suspension, Barium Sulfate Solution, and Magnetic Resonance Imaging |
| Placebo | Placebo comparator | Drug: Placebo, Procedure: Magnetic Resonance Imaging, Other: Barium Sulfate SolutionMatching placebo i.v. suspension, Barium Sulfate Solution, and Magnetic Resonance Imaging |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErythromycinAlso: Erythromycin suspension200 mg suspension | Drug | Erythromycin |
| PlaceboAlso: Water in 0.9% Sodium Chloride200 mg suspension | Drug | Placebo |
| Magnetic Resonance ImagingAlso: MRI, Magnetic Resonance EnterographyAn MR enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. | Procedure or surgery | Erythromycin, Placebo |
| Barium Sulfate SolutionAlso: VoLumenParticipants 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 | Erythromycin, Placebo |
Primary outcome
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.
5 secondary outcomes
Jejunal Volume
Time frame: Approximately 60 minutes after beginning ingestion of fluid volume
Ileal Volume
Time frame: Approximately 60 minutes after beginning ingestion of fluid volume
Colonic Volume
Time frame: Approximately 60 minutes after beginning ingestion of fluid volume
Small Intestine Volume
Time frame: Approximately 60 minutes after beginning ingestion of fluid volume
Small Intestine and Colon Volume
Time frame: Approximately 60 minutes after beginning ingestion of fluid volume
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeff Fidler, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Erythromycin, Magnetic Resonance Imaging and Barium Sulfate Solution in people with Healthy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric Volume (time frame: Approximately 60 minutes after beginning ingestion of fluid volume). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2016.