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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 below
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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:
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I have had stomach or upper intestine issues like ulcers, blockages, or certain diseases.
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I have difficulty swallowing.
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I am unable to understand and give consent for my own treatment.
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I am on medication that can affect my stomach or bowel movements.
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I have a gastrointestinal condition affecting muscle movement.
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I experience symptoms like nausea, vomiting, feeling full quickly, and stomach pain after eating.
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I do not have uncontrolled medical issues like high blood pressure or heart problems.
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I have had brain or abdominal surgery, but not for gallbladder or appendix removal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

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 • NCT01736540
3%
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
71,342 Total Patients Enrolled
3 Trials studying Gastroparesis
1,340 Patients Enrolled for Gastroparesis
National Institutes of Health (NIH)NIH
2,823 Previous Clinical Trials
8,162,883 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
John M Wo, MDPrincipal InvestigatorIndiana University School of Medicine
5 Previous Clinical Trials
1,331 Total Patients Enrolled
4 Trials studying Gastroparesis
331 Patients Enrolled for Gastroparesis

Media Library

Gastroparesis Subjects Clinical Trial Eligibility Overview. Trial Name: NCT04282317 — N/A
Gastroparesis Research Study Groups: Gastroparesis Subjects, Healthy Volunteer
Gastroparesis Clinical Trial 2023: Gastroparesis Subjects Highlights & Side Effects. Trial Name: NCT04282317 — N/A
Gastroparesis Subjects 2023 Treatment Timeline for Medical Study. Trial Name: NCT04282317 — N/A
~5 spots leftby Dec 2025
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