Status:
COMPLETED
A New Method for Determining Gastric Acid Output Using a Wireless Capsule
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Gastric Acid Secretory Disorders
Eligibility:
All Genders
18+ years
Brief Summary
Background: \- Acid-related gastrointestinal disorders are numerous and may require chronic treatment and maintenance, but they are often difficult to diagnose and treat. Gastric analysis is a critic...
Detailed Description
Acid related disorders are numerous and often require chronic treatment and maintenance. Many of these diseases are without symptoms and therefore difficult to diagnose and treat. Gastric analysis is ...
Eligibility Criteria
Inclusion
- CURRENTLY ONLY RECRUITING Patients with Zollinger Ellison Syndrome and Hypersecretion AND Patients with Refractory GERD, Peptic ulcer disease, Idiopathic Gastric Hypersecretion
- 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 \>200 pg/mL postinjection), gastric acid hypersecretion (BAO \> 15) in the presence of hypergastrinemia (fasting serum gastrin \> 99)
- Multiple endocrine neoplasia type-I (MEN1) with suspicion of ZES (hypergastrinemia) undergoing evaluation. MEN-I with ZES
- Hypergastrinemia (serum gastrin \> 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 surgery (gastrectomy, pyloroplasty)
- Use of bowel motility medications such as, but not limited to, Reglan, Immodium, and Lomotil
- 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 diverticulitis, 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
- Estabished diagnosis of gastroparesis
- Significant systemic or major illnesses including, but not limited to, stroke, congestive heart failure, renal failure (creatinine clearance \< 50 ml/min), organ transplantation, angina pectoris, active malignancy, and autonomic neuropathy
- Unstable psychiatric conditions, untreated or uncontrolled depression or generalized anxiety disorder, substance abuse within the past year, in order to prevent feeling of being uncomfortable or to prevent lack of follow-up
- Use of not-steroidal anti-inflammatory drugs for 2 weeks prior to study enrollment
- Phase IIIA, Use in Patients with Refractory GERD, Peptic ulcer disease, Idiopathic Gastric Hypersecretion
- INCLUSION:
- Gastric acid hypersecretion (BAO\>15 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 surgery (gastrectomy, pyloroplasty).
- Use of bowel motility medications such as, but not limited to, Reglan, Immodium, and Lomotil
- 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 diverticulitis, 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
- Established diagnosis of gastroparesis
- Significant systemic or major illnesses including, but not limited to, stroke, congestive heart failure, renal failure (creatinine clearance \< 50 ml/min), organ transplantation, angina pectoris, active malignancy, and autonomic neuropathy
- Unstable psychiatric conditions, untreated or uncontrolled depression or generalized anxiety disorders, substance abuse within the past year, in order to prevent feeling of being uncomfortable or to prevent lack of follow-up. Use of non-steroidal anti-inflammatory drugs for 2 weeks prior to study enrollment.
- Phase IIIB, Use in Patients with Medication-Controlled: GERD, Peptic ulcer disease, Idiopathic Gastric Hypersecretion
- INCLUSION:
- Medication-controlled (patients whose symptoms resolve with medication):GERD, PUD, and suspected idiopathic gastric hypersecretion
- Patients must meet the above inclusion criteria and the following
- Ages equal to or greater than 18 years
- Male, females, all ethnicities
- EXCLUSION:
- Refractory to medication: GERD (patients with persistant symptoms despite being on standard medical therapy), PUD, and suspected idiopathic gastric hypersecretion
- History of gastric surgery (gastrectomy, pyloroplasty).
- Use of bowel motility medications such as, but not limited to, Reglan, Immodium, and Lomotil
- 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 diverticulitis, 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
- Established diagnosis of gastroparesis
- Significant systemic or major illnesses including, but not limited to, stroke, congestive heart failure, renal failure (creatinine clearance \< 50 ml/min), organ transplantation, angina pectoris, active malignancy, and autonomic neuropathy
- Unstable psychiatric conditions, untreated or uncontrolled depression or genralized anxiety disorders, substance abuse within the past year, in order to prevent feeling of being uncomfortable or to prevent lack of follow-up
- Use of non-steroidal anti-inflammatory drugs for 2 weeks prior to study enrollment
- RECRUITMENT IS CLOSED FOR Phase IA/IB, Validation and Establishment of Nomogram in Healthy Volunteers
- PHASE IA/IB INCLUSION:
- Healthy volunteers
- Ages 18-60
- Males, females, all ethnicities
- PHASE IA/IB 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 \< 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
Exclusion
Key Trial Info
Start Date :
June 18 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00702533
Start Date
June 18 2008
Last Update
December 26 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892