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
National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 02/07/2009