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MRI Brain and Stomach Imaging for Gastroparesis
N/A
Waitlist Available
Led By John M Wo, MD
Research Sponsored by Indiana University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Healthy volunteers from 18 to 65 years of age
Be older than 18 years old
Must not have
Prior diagnosis of the upper GI disorders, including gastroparesis, gastric or duodenal ulcer, gastric outlet obstruction, acute or chronic pancreatitis, large hiatal or paraesophageal hernia, small intestinal bacterial overgrowth, celiac disease, Crohn's disease
Presence of dysphagia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
No Placebo-Only Group
Summary
This trial is to study a new imaging technique for the gut and brain.
Who is the study for?
This trial is for healthy volunteers aged 18-65 and those with gastroparesis symptoms lasting at least 12 weeks. Excluded are individuals unable to consent, allergic to pineapple, with certain medical conditions or surgeries, contraindications to MRI, or taking medications affecting GI motility.
What is being tested?
The study tests the use of MRI scans as a non-invasive method to image the gastrointestinal tract and explore brain-gut interactions in both healthy participants and those with gastroparesis symptoms.
What are the potential side effects?
MRI scans are generally safe but may cause discomfort due to loud noises during the scan or claustrophobia. There's also a small risk of an allergic reaction if contrast material is used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old and in good health.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had stomach or upper intestine issues like ulcers, blockages, or certain diseases.
Select...
I have difficulty swallowing.
Select...
I am unable to understand and give consent for my own treatment.
Select...
I am on medication that can affect my stomach or bowel movements.
Select...
I have a gastrointestinal condition affecting muscle movement.
Select...
I experience symptoms like nausea, vomiting, feeling full quickly, and stomach pain after eating.
Select...
I do not have uncontrolled medical issues like high blood pressure or heart problems.
Select...
I have had brain or abdominal surgery, but not for gallbladder or appendix removal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Gastric peristalsis
Secondary study objectives
Contraction frequency
Pylorus transit
Side effects data
From 2015 Phase 4 trial • 243 Patients • NCT017365403%
Febrile neutropenia
1%
Constipation
1%
Diarrhoea
1%
Gastrointestinal disorder
1%
Eye swelling
1%
Anaemia
1%
Malaise
1%
Pneumonia
1%
C-reactive protein increased
1%
Electrocardiogram QT prolonged
1%
Platelet count decreased
1%
Hypokalaemia
1%
Proctalgia
1%
Asthenia
1%
Oedema peripheral
1%
Pain
1%
Respiratory tract infection
1%
Heart rate increased
1%
Dehydration
1%
Insomnia
1%
Sleep disorder
1%
Haematuria
1%
Nasopharyngitis
1%
Pulmonary oedema
1%
Pyrexia
1%
Pruritus
1%
Hypotension
1%
Fatigue
1%
Thrombocytopenia
1%
Hypoacusis
1%
Dry eye
1%
Abdominal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Other Anaemia
Thalassaemia Major
Non-transfusion-dependent Anaemia (NTDT)
Myelodysplastic Syndrome (MDS)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Healthy VolunteerExperimental Treatment1 Intervention
This arm will enroll healthy volunteers as controls
Group II: Gastroparesis SubjectsExperimental Treatment1 Intervention
This arm will enroll a) patients with gastroparesis from type 1 diabetes and b) patients with gastroparesis from vagus nerve trauma
Find a Location
Who is running the clinical trial?
Purdue UniversityOTHER
233 Previous Clinical Trials
71,347 Total Patients Enrolled
3 Trials studying Gastroparesis
1,340 Patients Enrolled for Gastroparesis
National Institutes of Health (NIH)NIH
2,815 Previous Clinical Trials
8,161,616 Total Patients Enrolled
1 Trials studying Gastroparesis
22 Patients Enrolled for Gastroparesis
Indiana University School of MedicineLead Sponsor
192 Previous Clinical Trials
179,376 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had stomach or upper intestine issues like ulcers, blockages, or certain diseases.I have difficulty swallowing.I am unable to understand and give consent for my own treatment.I have had gastroparesis symptoms like nausea and pain for at least 12 weeks.I am on medication that can affect my stomach or bowel movements.You cannot have a magnetic resonance (MR) scan if you are pregnant, have certain medical implants (like a pacemaker or neural stimulator), or certain eye conditions.I am between 18 and 65 years old and in good health.I have a gastrointestinal condition affecting muscle movement.I experience symptoms like nausea, vomiting, feeling full quickly, and stomach pain after eating.I do not have uncontrolled medical issues like high blood pressure or heart problems.I have had brain or abdominal surgery, but not for gallbladder or appendix removal.You are allergic to pineapple.I have a history of brain-related illnesses or severe migraines needing medication.
Research Study Groups:
This trial has the following groups:- Group 1: Gastroparesis Subjects
- Group 2: Healthy Volunteer
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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