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Protocol Details

Pilot Assessment To Find Evidence of Gastric Motility Abnormalities in Eosinophilic Gastric Disorders

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

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)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Allergy and Infectious Diseases

Background:

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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Eligibility

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


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Citations:

Vitellas KM, Bennett WF, Bova JG, Johnson JC, Greenson JK, Caldwell JH. Radiographic manifestations of eosinophilic gastroenteritis. Abdom Imaging. 1995 Sep-Oct;20(5):406-13. doi: 10.1007/BF01213260. PMID: 7580773.

Tougas G, Eaker EY, Abell TL, Abrahamsson H, Boivin M, Chen J, Hocking MP, Quigley EM, Koch KL, Tokayer AZ, Stanghellini V, Chen Y, Huizinga JD, Ryd(SqrRoot)(Copyright)n J, Bourgeois I, McCallum RW. Assessment of gastric emptying using a low fat meal: establishment of international control values. Am J Gastroenterol. 2000 Jun;95(6):1456-62. doi: 10.1111/j.1572-0241.2000.02076.x. PMID: 10894578.

Assa'ad AH, Gupta SK, Collins MH, Thomson M, Heath AT, Smith DA, Perschy TL, Jurgensen CH, Ortega HG, Aceves SS. An antibody against IL-5 reduces numbers of esophageal intraepithelial eosinophils in children with eosinophilic esophagitis. Gastroenterology. 2011 Nov;141(5):1593-604. doi: 10.1053/j.gastro.2011.07.044. Epub 2011 Aug 9. PMID: 21835135.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Paneez Khoury, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
NIHBC 10 - CLINICAL CENTER BG RM 12C103
10 CENTER DR
BETHESDA MD 20892
(301) 402-3673
paneez.khoury@nih.gov

Nicole C. Holland-Thomas, R.N.
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health
Building 10
Room 6D44.18
10 Convent Drive
Bethesda, Maryland 20892
(301) 402-5969
hollandnc@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT05229432

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