A New Method for Determining Gastric Acid Output Using a Wireless Capsule
- Conditions
- Gastric Acid Secretory Disorders
- Interventions
- Device: Pentagastrin Injection BP
- Registration Number
- NCT00702533
- 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 critical tool for diagnosing and treating acid-related disorders; however, at present it requires a technically difficult procedure, using a nasogastric tube, that is costly, invasive, and uncomfortable. Recently a new tool, the SmartPill, has been developed that can measure acid levels, temperature, and pressure throughout the stomach, small intestine, and colon by swallowing a small capsule. Researchers are interested in comparing current methods of measuring stomach acid with the SmartPill by studying both healthy volunteers and individuals with acid-related gastrointestinal disorders.
Objectives:
- To evaluate the usefulness and accuracy of the SmartPill for gastric analysis, compared with current procedures.
Eligibility:
* Phase 1A/1B: Healthy volunteers between 18 and 60 years of age.
* Phase 2: Individuals at least 18 years of age who have been diagnosed with Zollinger-Ellison Syndrome or acid hypersecretion.
* Phase 3: Individuals at least 18 years of age who have been diagnosed with refractory gastroesophageal reflux disease, peptic ulcer disease, or idiopathic gastric hypersecretion.
Design:
* This study involves a screening visit, a 3-day inpatient study visit, and possible additional outpatient visits.
* Participants will be screened with a medical history and physical examination, as well as blood and urine samples.
* Phase 1A/1B: Participants will have a 3-day inpatient study visit with the following procedures:
* Imaging study of the stomach (simultaneous gastric emptying scintigraphy), followed by a special diet for the next day s test.
* Gastric analysis using a nasogastric tube to collect stomach acid secretions.
* SmartPill study, in which participants will ingest a SmartPill and wear a monitor for 24 to 48 hours to collect readings.
* Participants in Phase 1A will have a second outpatient SmartPill study 7 days after the first SmartPill study. Participants in Phase 1B will not have the second SmartPill study.
* Phase 2 and Phase 3: Participants will have a 3-day inpatient study visit with the following procedures:
* Imaging study of the stomach (simultaneous gastric emptying scintigraphy), followed by a special diet for the next day s test.
* Gastric analysis using a nasogastric tube to collect stomach acid secretions.
* SmartPill study, in which participants will ingest a SmartPill and wear a monitor for 24 to 48 hours to collect readings.
* Phase 2 and 3 participants will have outpatient study visits only if directed by the study researchers.
- 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 the quantitative measurement of gastric acid output and is a critical tool for the diagnosis of acid related disorders and the ongoing assessment of therapy response. At present gastric analysis requires a technically difficult procedure, using gastric aspiration through a nasogastric tube, that is costly, invasive, and uncomfortable for patients. Recently there is introduction of the SmartPill, which is a disposable pill that measures pH, temperature, and pressure throughout the GI tract. We propose a pilot study to validate a new method of gastric analysis with the ingestion of the SmartPill with a meal of a known buffering capacity to measure both the acidity and quantity of acid output in the stomach. We will validate this method by comparing it to the accepted gastric aspiration method under maximally stimulated conditions. We will study healthy volunteers for the validation phase and then study patients with known acid related disorders to assess its usefulness in patients. Interested subjects will report to the NIH outpatient gastrointestinal clinic for evaluation to be followed by a 3 day in-patient admission and 2 subsequent clinic visits. Subjects will have gastric analysis of basal, meal stimulated, and pharmacologically stimulated rates with both the conventional and study methods. Outcomes will include a quantitative measurement of gastric acid output in unit time, normal meal stimulated acid output values in healthy volunteers and patients with acid related disorders, and the assessment of acid suppression in patients treated with a variety of anti-secretory medications.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Healthy volunteers Pentagastrin Injection BP Healthy volunteers between 18 and 60 years of age patients with gastric acid secretory disorders Pentagastrin Injection BP 18 years of age who have been diagnosed with Zollinger-Ellison Syndrome or acid hypersecretion. patients with gastric acid secretory disorders Pentagastrin 18 years of age who have been diagnosed with Zollinger-Ellison Syndrome or acid hypersecretion.
- Primary Outcome Measures
Name Time Method examines the safety and efficacy of disposable, wireless capsule (SmartPill) until protocol closes This study examines the safety and efficacy of disposable, wireless capsule (SmartPill) devices in determining gastric acid output in comparison to current standard gastric aspiration procedures, which are more invasive and inconvenient.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States