Dyspepsia, Gastroparesis
Conditions
Brief summary
This is a feasibility study to assess the utility of magnetically controlled capsule endoscopy in the evaluation of gastroparesis and functional dyspepsia
Detailed description
Gastroparesis and functional dyspepsia can both present with abdominal pain, dyspepsia, nausea, emesis, or early satiety. Gastroparesis is a syndrome defined as delayed gastric emptying. Functional dyspepsia is a symptom-based diagnosis in which the pathophysiology is multifactorial. Delayed gastric emptying is present in 25-35% of patients with functional dyspepsia. The study investigators propose the Navicam magnetically controlled capsule endoscopy (MCCE) system as a potential new method of evaluating gastric motility disorders. The MCCE is FDA approved for visualization of the stomach. The ability to visualize gastric peristalsis in real time, without interference from an endoscope, has never been demonstrated. The MCCE system could allow physicians to evaluate gastric motility with a test that has clear advantages over the current methods: it is fast, non-invasive, and has no radiation exposure, has artificial intelligence (AI) capabilities, while at the same time provides a visual assessment of the gastric anatomy. In this pilot feasibility study, the study investigators plan to enroll 5 male and female adult healthy volunteers, 5 male and female patients with gastroparesis, 5 male and female patients with functional dyspepsia (epigastric pain syndrome and/or postprandial distress syndrome with or without gastric emptying delay), and 2 patients with gastroparesis who have undergone a G-POEM procedure. The study investigators will compare gastric motor patterns in the different sections of the stomach and symptoms during fasting and a sham meal between groups.
Interventions
This is a diagnostic device for gastric disorders used to diagnose mucosal abnormalities. In this study it will be evaluated for use in gastric motility.
Sponsors
University of California, Los Angeles
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Four groups of participants will be studied: gastroparesis, functional dyspepsia, gastroparesis patients s/p G-POEM, and healthy controls.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Must meet one of the following categories: 1. Gastroparesis Meets diagnostic criteria for gastroparesis: 1. Evidence of delayed gastric emptying documented with a standard 2 hour or 4 hour gastric emptying scintigraphy exam 2. Absence of mechanical obstruction 3. Exhibits cardinal symptoms of early satiety, post-prandial fullness, nausea, vomiting, bloating, and upper abdominal pain Gastrointestinal cardinal symptom index (GCSI) score \> 0 (i.e., the presence of at least mild severity of \>1 of 3 symptoms of nausea/vomiting, postprandial fullness/early satiety, and/or bloating). 2. Functional Dyspepsia Meets Rome IV diagnostic criteria for functional dyspepsia: 1. Criteria fulfilled for the last 3 months with symptom onset at least six months prior to diagnosis 2. No evidence of organic, systemic, or metabolic disease that is likely to explain the symptoms on routine investigations (including at upper endoscopy) 3. Meet criteria for Epigastric pain syndrome and/or Postprandial distress syndrome Epigastric Pain Syndrome At least 1 of the following symptoms at least 1 day per week 1. Bothersome epigastric pain 2. Bothersome epigastric burning Postprandial Distress Syndrome At least 1 of the following symptoms at least 3 days per week 1. Bothersome postprandial fullness 2. Bothersome early satiation 3. G-POEM 1. The G-POEM procedure must have been performed at least 4 weeks prior to screening. 2. GCSI score is \< 3 which correlates to mild or less symptom severity. 4. Controls None of the above conditions
Exclusion criteria
1. Another active disorder or treatment which could explain or contribute to symptoms in the opinion of the Investigator (including but not limited to gastric malignancy, neurological disorder, or heavy doses of strong anticholinergics). 2. Gastrectomy, fundoplication, vagotomy, bariatric surgery, post-surgical cause of gastroparesis, or gastric stimulation device surgically implanted within the last year. Prior G-POEM procedure for gastroparesis is allowed for the group of post-G-POEM study subjects. 3. Dysphagia, swallowing disorder 4. Suspected bowel obstruction or perforation 5. Gastric or parenteral feeding within 4 weeks of screening 6. Pregnancy or nursing 7. History of an eating disorder within 2 years of screening 8. Recent history (within six months of screening) of Alcohol Use Disorder or Substance Use Disorder as defined in DSM-5. 9. Uncontrolled thyroid disease 10. Unstable cardiac, respiratory, hepatic or renal disease 11. Evidence of uncontrolled blood glucose (including HbA1C \>9 or metabolic crisis in past 60 days). 12. Use of prohibited medication or medication with anti-nausea, antiemetic, neuromodulating, or prokinetic effect within 2 weeks of the screening visit EXCEPT when administered on a stable daily dosing schedule (stable for at least 1 month prior to the screening visit). 13. Use of as needed or daily opioids within the past 1 month. 14. Pyloric injection of neurotoxins (e.g. botulinum type A or B) within 3 months of the Screening visit. 15. Altered mental status (e.g., hepatic encephalopathy) that limits the ability to swallow a capsule 16. Expected to have Magnetic Resonance Imaging (MRI) examination within 30 days. 17. No reliable contact information - no phone, no permanent address. 18. Pacemaker or ICD 19. Inability to avoid using the bathroom for urination and/or bowel movements for the duration of the study. 20. Metal Implant (ie metal hip arthroplasty, surgical mesh, coronary or arterial stent) 21. Prior bowel surgery 22. Severe claustrophobia 23. Any other reason as determined by the Investigator which may lead to an unfavorable risk-benefit of study participation, may interfere with study compliance, or may confound study results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Contractions at Baseline | Comparison between stomach contractions at baseline (Stage 1/ before sham meal) | Physiologic parameter measuring the frequency and direction of stomach contractions at baseline (before sham meal). |
| Largest Diameter of the Pylorus | assessed after the sham meal (stage II, completed within 2 hours of baseline) | Physiologic parameter measuring the diameter of the pylorus |
| Dyspepsia Severity Scale Symptom Ratings at Baseline. | Assessed at baseline. | Evaluating the dyspepsia Severity Scale symptom ratings (range of score 0-20; with higher scores indicating more severe symptoms of dyspepsia) at baseline. |
| Number of Participants With Procedure Related Adverse Events | Through participants' study participation, approximately 1 day | Procedure related adverse events during or after the study session |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLin Chang, MD
University of California, Los Angeles
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 34.3 years STANDARD_DEVIATION 10.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 5 | 0 / 5 | 0 / 0 |
| other Total, other adverse events | 0 / 6 | 0 / 5 | 0 / 5 | 0 / 0 |
| serious Total, serious adverse events | 0 / 6 | 0 / 5 | 0 / 5 | 0 / 0 |
Outcome results
None listed