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Comparative Assessment of Radioisotope Glucose and Breath Test

NCT04499742 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2020-08-05

No results posted yet for this study

Summary

This is a research study about improving our diagnostic method for small intestinal bacterial overgrowth (SIBO). Patients undergoing Standard of Care (SOC) Endoscopically assisted glucose breath test (EAGBT) will undergo upper endoscopy and glucose breath tests. In this study, investigators wish to utilize Nuclear Medicine techniques to locate where the glucose solution that is administered during EAGBT is being consumed by bacteria is in the small bowel when it detects SIBO.

Conditions

  • Small Intestinal Bacterial Overgrowth

Interventions

RADIATION

Using Isotope (Tc99m-Sulfur Colloid) to label glucose and administer this directly into duodenum.

Patients will be undergoing Standard of Care procedure EAGBT for collection of duodenal fluid (aspirate and culture) and placement of a catheter into the duodenum. This catheter will be used for infusion of glucose isotope into the small bowel. Subsequently Standard of Care nuclear medicine imaging will be used to track the location of the isotope in the gut.

Sponsors & Collaborators

  • Augusta University

    lead OTHER

Principal Investigators

  • Satish Rao, MD, PhD · Augusta University

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-21
Primary Completion
2021-12-14
Completion
2021-12-14
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT04499742 on ClinicalTrials.gov