Comparative Assessment of Radioisotope Glucose and Breath Test

NCT04499742 | Unknown FDA Device

• 1 other identifier: 1328690
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Correlation between GBT result and isotope detection in small bowel

  Overall correlation (positive and negative) between the location of glucose isotope in small bowel (imaging) and changes in in hydrogen and methane values obtained during the breath test.

  February 6, 2019 (anticipated) - December 14, 2021 (anticipated)

Secondary Outcomes (3)

• Diagnostic yield of EAGBT compared to oral GBT

  February 6, 2019 (anticipated) - December 14, 2021 (anticipated)

• Diagnostic yield of EAGBT compared to duodenal aspirate and culture

  February 6, 2019 (anticipated) - December 14, 2021 (anticipated)

• Symptom patterns and demographics

  February 6, 2019 (anticipated) - December 14, 2021 (anticipated)

Interventions

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

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients exhibiting SIBO symptoms.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

Augusta University Digestive Health Research

Augusta, Georgia, 30912, United States

RECRUITING

Biospecimen

Retention: NONE RETAINED

Breath samples will be analyzed using gas chromatography for hydrogen and methane values.

MeSH Terms

Interventions

Technetium Tc 99m Sulfur Colloid

Intervention Hierarchy (Ancestors)

Sulfur Compounds; Inorganic Chemicals; Technetium Compounds

Study Officials

• Satish Rao, MD, PhD

  Augusta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tennekoon Karunaratne, MD, PhD

CONTACT

7067211968; tkarunaratne@augusta.edu

Audrey Eubanks, BS

CONTACT

7067211968; aueubanks@augusta.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: August 5, 2020
• Study Start: January 21, 2019
• Primary Completion: December 14, 2021
• Study Completion: December 14, 2021
• Last Updated: August 5, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)