• PHASE IA/IB

INCLUSION:

Healthy volunteers

Ages 18-60

Males, females, all ethnicities

EXCLUSION:

History of gastric or bowel surgery

Use of bowel motility medications such as, but not limited to, Reglan, Immodium, and Lomotil

Use of antacid, antisecretory, and anticholinergic medications such as, but not limited to, proton pump inhibitors and histamine 2 receptor antagonists

Use of non-steroidal anti-inflammatory drugs for 2 weeks prior to study enrollment

Hypersecretory and hyposecretory related conditions including, but not limited to, pernicious anemia, atrophic gastritis, and Zollinger-Ellison syndrome

Contraindication to NGT: deviated septum, history of transphenoidal surgery, chronic sinusitis, severe facial trauma (cribriform plate disruption, sustained head trauma, maxillofacial injury, or anterior fossa skull fracture), esophageal stricture, esophageal varices, altered mental status, and impaired airway

Contraindication to scintigraphy: allergy to sulfa-colloid

Contraindication to pentagastrin: allergy to pentagastrin, active gastrointestinal bleeding, active peptic ulcer disease, active gallbladder and liver disease, pancreatitis, and bowel obstruction

Contraindication to SmartPill: history of gastric bezoar, disorders of swallowing, suspected strictures, fistulas, or physiological GI obstruction, GI surgery within the past three months, severe dysphagia to food or pills, Crohns disease or diverticulosis, and implanted or portable electro-mechanical medical device such as a cardiac pacemaker or infusion pump

Pregnancy and breastfeeding. Females of childbearing potential must be on an acceptable means of birth control and no intercourse in 2 weeks prior to study enrollment.

Lactose intolerance or inability to drink standard meal of Ensure Plus

Helicobacter pylori infection

Gastroparesis

History of gastroesophageal reflux disease, peptic ulcer disease, irritable bowel syndrome, or inflammatory bowel disease

Significant systemic or major illnesses including, but not limited to, stroke, cardiovascular disease, hypertension, congestive heart failure, renal failure (creatinine clearance less than 50 ml/min), organ transplantation, angina pectoris, active malignancy, diabetes, or autonomic neuropathy

Unstable psychiatric conditions, depression, generalized anxiety disorder, or substance abuse within the past year, in order to prevent feeling of being uncomfortable or to prevent lack of follow-up

PHASE II, Use in Patients with Zollinger Ellison Syndrome and Hypersecretion

INCLUSION:

Zollinger-Ellison syndrome (ZES) as diagnosed by one of the following criteria: histologic confirmation of gastrinoma, positive provocative testing with secretin (an increase of greater than 200 pg/mL postinjection), gastric acid hypersecretion (BAO greater than 15) in the presence of hypergastrinemia (fasting serum gastrin greater than 99)

Multiple endocrine neoplasia type-I (MEN1) with suspicion of ZES (hypergastrinemia) undergoing evaluation. MEN-I with ZES

Hypergastrinemia (serum gastrin greater than 99)

Patients must meet at least 1 of the above inclusion criteria and the following:

Ages equal to or greater than 18 years

Male, females, all ethnicities

EXCLUSION:

History of gastric or bowel surgery

Use of bowel motility medications such as, but not limited to, Reglan, Immodium, and Lomotil

Contraindication to NGT: deviated septum, history of transphenoidal surgery, chronic sinusitis, severe facial trauma (cribriform plate disruption, sustained head trauma, maxillofacial injury, or anterior fossa skull fracture), esophageal stricture, esophageal varices, altered mental status, and impaired airway

Contraindication to SmartPill: history of gastric bezoar, disorders of swallowing, suspected strictures, fistulas, or physiological GI obstruction, GI surgery within the past three months, severe dysphagia to food or pills, Crohn's Disease or diverticulosis, a subject who uses an implanted or portable electro-mechanical medical device such as a cardiac pacemaker or infusion pump

Pregnancy and breastfeeding. Females of childbearing potential must be on an acceptable means of birth control and no intercourse in 2 weeks prior to study enrollment.

Lactose intolerance or inability to drink standard meal of Ensure Plus

Gastroparesis

Significant systemic or major illnesses including, but not limited to, stroke, congestive heart failure, renal failure (creatinine clearance less than 50 ml/min), organ transplantation, angina pectoris, active malignancy, and autonomic neuropathy

Unstable psychiatric conditions, depression, generalized anxiety disorder, substance abuse within the past year, in order to prevent feeling of being uncomfortable or to prevent lack of follow-up

Helicobacter pylori infection

PHASE III, Use in Patients with Refractory GERD, Peptic ulcer disease, Idiopathic Gastric Hypersecretion

INCLUSION:

Gastric acid hypersecretion (BAO greater than15 mEq/hr)

Conditions with gastric acid hypersecretion including, but not limited to, patients with systemic mastocytosis (SM)

Refractory GERD (patients with persistant symptoms despite being on standard medical therapy), PUD, and suspected idiopathic gastric hypersecretion

Patients must meet at least 1 of the above inclusion criteria and the following:

Ages equal to or greater than 18 years

Male, females, all ethnicities

EXCLUSION:

History of gastric or bowel surgery

Use of bowel motility medications such as, but not limited to, Reglan, Immodium, and Lomotil

Contraindication to NGT: deviated septum, history of transphenoidal surgery, chronic sinusitis, severe facial trauma (cribriform plate disruption, sustained head trauma, maxillofacial injury, or anterior fossa skull fracture), esophageal stricture, esophageal varices, altered mental status, and impaired airway

Contraindication to SmartPill: history of gastric bezoar, disorders of swallowing, suspected strictures, fistulas, or physiological GI obstruction, GI surgery within the past three months, severe dysphagia to food or pills, Crohn's Disease or diverticulosis, a subject who uses an implanted or portable electro-mechanical medical device such as a cardiac pacemaker or infusion pump

Pregnancy and breastfeeding. Females of childbearing potential must be on an acceptable means of birth control and no intercourse in 2 weeks prior to study enrollment.

Lactose intolerance or inability to drink standard meal of Ensure Plus

Gastroparesis

Significant systemic or major illnesses including, but not limited to, stroke, congestive heart failure, renal failure (creatinine clearance less than 50 ml/min), organ transplantation, angina pectoris, active malignancy, and autonomic neuropathy

Unstable psychiatric conditions, depression, generalized anxiety disorder, substance abuse within the past year, in order to prevent feeling of being uncomfortable or to prevent lack of follow-up

Helicobacter pylori infection