Ignite Creation Date:
2024-05-06 @ 3:00 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04499742
Status:
UNKNOWN
Last Update Posted:
2020-08-05
First Post:
2019-02-19
Brief Title:
Comparative Assessment of Radioisotope Glucose and Breath Test
Sponsor:
Augusta University
Organization:
Augusta University
Study Overview
Official Title:
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
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 andor ileum Diagnosis of SIBO requires either duodenal aspirate with culture analysis or more commonly with breath hydrogenmethane 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 ie 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 andor 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 aspiratecultures taken at the time of endoscopy Clinical response to treatment will be assessed on follow up
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 ie 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 andor 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 aspiratecultures taken at the time of endoscopy Clinical response to treatment will be assessed on follow up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None