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
试验速览
- 阶段
- 不适用
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Correlation between GBT result and isotope detection in small bowel
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with recent gas, bloating, distension, and suspected SIBO
- •Negative oral GBT
- •18 years and older
排除标准
- •Pregnancy
- •Previous abdominal surgery except cholecystectomy, appendectomy
- •Diet prep non-adherence
- •Smoking or exercise causing hyperventilation prior to exam
结局指标
主要结局
Correlation between GBT result and isotope detection in small bowel
时间窗: February 6, 2019 (anticipated) - December 14, 2021 (anticipated)
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.
次要结局
- Symptom patterns and demographics(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))
- Diagnostic yield of EAGBT compared to oral GBT(February 6, 2019 (anticipated) - December 14, 2021 (anticipated))
研究者
Satish Rao
Professor, MD, PhD
Augusta University
