NCT04910815

Feasibility of a New Diagnostic Device to Assess Small Intestinal Dysbiosis in Routine Clinical Setting.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Atmo Biosciences Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if the gas-sensing capsule can be used to identify increased numbers and a change of the composition of microbiota or microorganisms in the gut to assess small intestinal dysbiosis

Detailed description

In order to diagnose an increased bacterial density in the small intestine (e.g small intestinal bacterial overgrowth) metabolic activity of the microbiota colonising the small intestine is measured by exposing these bacteria with readily fermentable carbohydrates and measure subsequently (e.g. for 2 hrs) the change of the concentration of hydrogen (H2) and/or methane in the exhaled breath that results from carbohydrate fermentation in the small intestine. This is the principle of existing breath hydrogen tests, but they are poor at distinguishing where in the intestine the H2 is being produced, and their sensitivity is diminished by 'noise' in the breath H2 as a consequence of hydrogen or methane producing bacteria in the colon and this is frequently observed in the routine clinical setting. These shortcomings can be theoretically overcome by using the Atmo Gas CapsuleR which measures after ingestion gas concentrations during gastrointestinal transit in the lumen of the gut. As a consequence at the site of fermentation parts per hundred can be measured, rather than the parts per million (ppm) when methane or hydrogen are measured in the exhaled breath. An additional advantage is that the location of the capsule is known, and therefore the source of gas production from increased bacterial load can be determined. Preliminary studies using the gas capsule have shown good correlation of patterns of breath H2 with those of regional H2 patterns generated by the gas-sensing capsule. In fact, the capsule demonstrated far greater sensitivity in measuring H2 production and a vastly superior signal-to-noise ratio in response to a fermentable load than breath testing. Hence, investigating the utility of the gas-sensing capsule as a means for 'direct' assessment of microbial density presents an opportunity to overcome the shortcomings associated with the current breath test.

Conditions

• Small Intestinal Bacterial Overgrowth

Interventions

Type	Name	Description
DEVICE	Atmo Gas Capsule	The Atmo gas capsule is an ingestible electronic device. This capsule consists of gas and temperature sensors, electronic circuits, radio transmitter and silver oxide batteries. It can measure the concentrations and types of intestinal gases in individuals and give an indication of gut transit time. This data is used for research purposes to gain an understanding of the microbiota's localised functionality. The data from the sensors is transmitted out of the body over the radio frequency to a handheld receiver. The capsule passes out of the human body at the end of the measurement and is disposable.
DIAGNOSTIC_TEST	Glucose Breath Test	Glucose is a sugar that will be broken down by bacteria if present in the small bowel with hydrogen gas as a by-product. The hydrogen produced through fermentation is measured in the patients exhaled breath
DIAGNOSTIC_TEST	Fructoolifosaccharides (FOS) Breath Test	FOS is a long chain carbohydrate that can only be broken down by bacteria with hydrogen gas as a by-product. The hydrogen produced through fermentation is measured in the patients exhaled breath
PROCEDURE	Jejunal Aspiration and culture	Endoscopic procedure to determine microbial load of the Small bowel. This is the gold standard to determine the Active SIBO cases
DRUG	Rifaximin	Rifaximin (550g) 1 capsule twice a day for 14 days.
DRUG	Placebo	randomised administration of either placebo or Rifaximin (550g) 1 capsule twice a day for 14 days. The placebo will be encapsulated maize starch and pregelatinised maize starch

Timeline

• Start date: 2021-07-14
• Primary completion: 2024-06-01
• Completion: 2024-08-01
• First posted: 2021-06-02
• Last updated: 2024-01-30

Locations

2 sites across 2 countries: Australia, India