This study is currently recruiting participants.
Number
000281-I
Sponsoring Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Max Age: 59
Referral Letter Required
No
Population Exclusion(s)
Children
Keywords
Gastric Emptying Scintigraphy; Gastroparesis; Radiolabelled; Oatmeal; Natural History
Recruitment Keyword(s)
None
Condition(s)
Eosinophilic Gastritis; Gastric Motility
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Supporting Site
National Institute of Allergy and Infectious Diseases
Eosinophilic gastritis (EoG) is a rare disease that affects the gastrointestinal tract. Some people with EoG have symptoms that suggest that their stomachs may be slow to empty when they eat. But the stomach function of people with EoG has not been studied.
Objective:
This natural history study will explore whether some people with EoG might also have problems with emptying of the stomach.
Eligibility:
People aged 18 to 59 years with EoG who also have symptoms such as nausea, vomiting, bloating, and feeling full after eating only a small amount of food.
Design:
Participants will have 4 clinic visits within 18 weeks.
Visit 1: Participants will have a physical exam. They will fill out a questionnaire about their symptoms and daily living. They will fill out the questionnaire at least 3 times during the study.
Visit 2: Participants will have a gastric emptying study. They will eat a small amount of oatmeal with a radioactive tracer. They will have up to 5 imaging scans per hour for up to 4 hours. They will have blood tests.
Visit 3: Participants will have an upper endoscopy. They will go under anesthesia. A long tube with a camera will be inserted through their mouth and down into their stomach and upper small intestine. Small tissue samples may be taken.
Visit 4: Participants will have a water load test (this may also be done during visit 1). They will drink water until they feel full. The amount they drink will be recorded.
A study doctor will discuss any recommended treatments based on the participant s tests.
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INCLUSION CRITERIA: - Participant must be able to understand and provide informed consent - Age >=18 to <=59 at the time of screening - Eosinophilic gastritis defined as at least one endoscopy with histopathologic evidence of >=30 eosinophils in 5 or more hpf with associated symptoms of EoG - Patient reported symptoms starting at least 6 months or more prior to screening consistent with a diagnosis of EoG such as: nausea, vomiting, early satiety, abdominal pain or bloating, regurgitation, or diarrhea - Symptoms suggestive of a possible gastric motility disorder during the 60 days prior to screening including: nausea, vomiting, early satiety, post-prandial feeling of fullness, or bloating. - Tolerance and willingness to consume the oatmeal meal in this study - Must be willing to allow for samples collected during the study to be stored and used and/or shared with other collaborators in the future EXCLUSION CRITERIA: - Eosinophilic esophagitis with chronic or severe strictures (<10 mm that cannot be traversed by standard endoscope) - Diagnosis of severe eosinophilic enteritis (i.e severe endoscopic features of ulcerations, strictures, narrowing) - Inflammatory bowel disease (e.g. Crohn s disease or ulcerative colitis) - Known monogenic, genetic, or connective tissue disorders associated with eosinophilic GI diseases (e.g. D816V KIT+ systemic mastocytosis, Marfan syndrome, or Loeys Dietz Syndrome) - Known inflammatory or autoimmune disorders associated with gastric dysmotility such as systemic sclerosis, lupus, or eosinophilic fasciitis. - Uncontrolled diabetes; defined as hemoglobin (Hb)A1c (%) of 7% or more within 60 days of screening or known diabetic complications of gastroparesis, neuropathy, or nephropathy. - Uncontrolled thyroid disease (i.e., abnormal thyroid-stimulating hormone [TSH]) in the past 2 months - Women who are pregnant or nursing - Taking gastric motility agents (e.g., domperidone, metoclopramide, prucalopride, or erythromycin), anticholinergic antiemetics within 7 days or 4.5 half-lives (whichever is longer) in the days prior to GES or endoscopy. - Taking opioid agents in the two weeks prior to screening and throughout the study (except for medications administered peri-endoscopy). - History of GI neuromodulation or injection therapies, such as gastric electrical stimulation, botulinum toxin injections, or intrapyloric corticosteroid injections. - History of strictures in the small bowel or stomach (e.g., pyloric stenosis) or gastric surgeries or procedures such as pyloromyotomy, pyloric dilation, pyloric resection, vagotomy, bariatric surgery. or post-Nissen fundoplication or antrectomy with Billroth I, Billroth II, or Roux-en-Y gastrojejunostomy. - Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant s ability to comply with study requirements, may impact the quality or interpretation of the data obtained from the study, or compromise safely completing motility assessments or symptom questionnaires, such as: -- Advanced liver disease (Child's B or C) -- Acute or chronic renal disease (serum creatinine >3 mg/dL) -- Neurologic disease (e.g., dysautonomia) -- Achalasia -- Adrenal insufficiency
- Participant must be able to understand and provide informed consent
- Age >=18 to <=59 at the time of screening
- Eosinophilic gastritis defined as at least one endoscopy with histopathologic evidence of >=30 eosinophils in 5 or more hpf with associated symptoms of EoG
- Patient reported symptoms starting at least 6 months or more prior to screening consistent with a diagnosis of EoG such as: nausea, vomiting, early satiety, abdominal pain or bloating, regurgitation, or diarrhea
- Symptoms suggestive of a possible gastric motility disorder during the 60 days prior to screening including: nausea, vomiting, early satiety, post-prandial feeling of fullness, or bloating.
- Tolerance and willingness to consume the oatmeal meal in this study
- Must be willing to allow for samples collected during the study to be stored and used and/or shared with other collaborators in the future
EXCLUSION CRITERIA:
- Eosinophilic esophagitis with chronic or severe strictures (<10 mm that cannot be traversed by standard endoscope)
- Diagnosis of severe eosinophilic enteritis (i.e severe endoscopic features of ulcerations, strictures, narrowing)
- Inflammatory bowel disease (e.g. Crohn s disease or ulcerative colitis)
- Known monogenic, genetic, or connective tissue disorders associated with eosinophilic GI diseases (e.g. D816V KIT+ systemic mastocytosis, Marfan syndrome, or Loeys Dietz Syndrome)
- Known inflammatory or autoimmune disorders associated with gastric dysmotility such as systemic sclerosis, lupus, or eosinophilic fasciitis.
- Uncontrolled diabetes; defined as hemoglobin (Hb)A1c (%) of 7% or more within 60 days of screening or known diabetic complications of gastroparesis, neuropathy, or nephropathy.
- Uncontrolled thyroid disease (i.e., abnormal thyroid-stimulating hormone [TSH]) in the past 2 months
- Women who are pregnant or nursing
- Taking gastric motility agents (e.g., domperidone, metoclopramide, prucalopride, or erythromycin), anticholinergic antiemetics within 7 days or 4.5 half-lives (whichever is longer) in the days prior to GES or endoscopy.
- Taking opioid agents in the two weeks prior to screening and throughout the study (except for medications administered peri-endoscopy).
- History of GI neuromodulation or injection therapies, such as gastric electrical stimulation, botulinum toxin injections, or intrapyloric corticosteroid injections.
- History of strictures in the small bowel or stomach (e.g., pyloric stenosis) or gastric surgeries or procedures such as pyloromyotomy, pyloric dilation, pyloric resection, vagotomy, bariatric surgery. or post-Nissen fundoplication or antrectomy with Billroth I, Billroth II, or Roux-en-Y gastrojejunostomy.
- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant s ability to comply with study requirements, may impact the quality or interpretation of the data obtained from the study, or compromise safely completing motility assessments or symptom questionnaires, such as:
-- Advanced liver disease (Child's B or C)
-- Acute or chronic renal disease (serum creatinine >3 mg/dL)
-- Neurologic disease (e.g., dysautonomia)
-- Achalasia
-- Adrenal insufficiency
Principal Investigator
Referral Contact
For more information: