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A New Method for Determining Gastric Acid Output Using a Wireless Capsule

NCT00702533 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Gastric Acid Secretory Disorders

Interventions

DEVICE

Pentagastrin Injection BP

DRUG

Pentagastrin

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Stephen A Wank, M.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-18

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00702533 on ClinicalTrials.gov