Comparative Assessment of Radioisotope Glucose and Breath Test

Does Rise in Breath Hydrogen During Endoscopically Assisted Glucose Breath Test (EAGBT) Correlate With Radio-Isotope Location in Small Bowel: Improving Detection of Distal SIBO

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.

Study Overview

• Status: Unknown
• Conditions: Small Intestinal Bacterial Overgrowth
• Intervention / Treatment: Radiation: Using Isotope (Tc99m-Sulfur Colloid) to label glucose and administer this directly into duodenum.

Detailed Description

Small intestinal bacterial overgrowth (SIBO) is characterized by bloating, gas, distention, and diarrhea due to colonization and an excessive amount of bacteria in the small bowel. Distal SIBO is the presence of excessive amounts of bacteria in the distal jejunum and/or ileum. Diagnosis of SIBO requires either duodenal aspirate with culture analysis or more commonly with breath hydrogen/methane testing. Hydrogen breath testing often uses either oral glucose or lactulose solutions. If bacteria are present in the small bowel they will ferment glucose or lactulose, producing hydrogen or methane as a byproduct. These gases are absorbed into the bowel, and then eliminated via pulmonary expiration. By detecting a rise in breath H2 and CH4 values compared to baseline, SIBO can be diagnosed. However, after oral ingestion, the majority of the glucose substrate is absorbed in the duodenum and proximal jejunum. Therefore, Glucose breath test (GBT) is good for the detection of proximal SIBO, but misses distal SIBO.

Investigators have recently shown that glucose administration into the distal duodenum through upper endoscopy has a higher positive yield for SIBO in patients with negative oral GBT. However, it is unclear if the rise in breath H2 or CH4 is because of glucose fermentation by bacteria in the distal small bowel or from fermentation by bacteria in the colon, i.e. false-positive test. Study objective here is to administer a radio-labeled glucose solution into the duodenum via an endoscopically placed nasoduodenal tube, and then determine if the rise in breath hydrogen and/or methane correlates with the location of the isotopic glucose solution in the bowel by simultaneous nuclear imaging. Results of breath testing will also be compared with duodenal aspirate/cultures taken at the time of endoscopy. Clinical response to treatment will be assessed on follow up.

• Study Type: Observational
• Enrollment (Anticipated): 25

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Recruiting
      • Augusta University Digestive Health Research
      • Contact: Audrey Eubanks, BS; Phone Number: 7067211968; Email: aueubanks@augusta.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients exhibiting SIBO symptoms.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic yield of EAGBT compared to oral GBT	We will compare the yield (positive, negative and overall) of endoscopic assisted GBT versus orally administered GBT	February 6, 2019 (anticipated) - December 14, 2021 (anticipated)
Diagnostic yield of EAGBT compared to duodenal aspirate and culture	We will compare the positive and negative yield of EAGBT with the positive (>1000 CFU/ml) or negative yield of aerobic and anaerobic cultures.	February 6, 2019 (anticipated) - December 14, 2021 (anticipated)
Symptom patterns and demographics	Compare the gas and bloating symptom patterns, clinical characteristics predisposing factors including underlying dysmotility and other demographic features between patients with positive and negative EAGBT and cultures.	February 6, 2019 (anticipated) - December 14, 2021 (anticipated)

Collaborators and Investigators

• Sponsor: Augusta University
• Investigators: Principal Investigator: Satish Rao, MD, PhD, Augusta University

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2019
• Primary Completion (Anticipated): December 14, 2021
• Study Completion (Anticipated): December 14, 2021

Study Registration Dates

• First Submitted: February 19, 2019
• First Submitted That Met QC Criteria: August 4, 2020
• First Posted (Actual): August 5, 2020

Study Record Updates

• Last Update Posted (Actual): August 5, 2020
• Last Update Submitted That Met QC Criteria: August 4, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Technetium Tc 99m Sulfur Colloid
• Other Study ID Numbers: 1328690

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No