Recruiting

Radioisotope vs. Breath Test

Sponsor:

Augusta University

Code:

NCT04499742

Conditions

Small Intestinal Bacterial Overgrowth

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief 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

Study ID

NCT04499742

Start date

Jan 21, 2019

Status verified date

Aug, 2020

Completion date

Dec 14, 2021

Anticipated

Primary completion date

Dec 14, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients with recent gas, bloating, distension, and suspected SIBO
  • Negative oral GBT
  • 18 years and older

Exclusion Criteria:

  • Pregnancy
  • Diabetes
  • Previous abdominal surgery except cholecystectomy, appendectomy
  • Diet prep non-adherence
  • Smoking or exercise causing hyperventilation prior to exam

Study Design

Enrollment

25 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • Correlation between GBT result and isotope detection in small bowel [ Time Frame: February 6, 2019 (anticipated) - December 14, 2021 (anticipated) ]

Central Contacts and Locations

Central contacts

Tennekoon Karunaratne, MD, PhD

7067211968tkarunaratne@augusta.edu

Audrey Eubanks, BS

7067211968aueubanks@augusta.edu

Locations

Augusta University Digestive Health Research

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Tennekoon Karunaratne, MD, PhD

706-721-1968tkarunaratne@augusta.edu

Audrey Eubanks, BS

7067211968aueubanks@augusta.edu

Principal Investigator:

Satish Rao, MD, PhD

More Information

Sponsor

Augusta University

Last update posted

Aug 5, 2020

Last verified

Aug, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Augusta University on 2020-08-05.