Clinical trial NCT04910815: Feasibility of a New Diagnostic Device to Assess Small Intestinal Dysbiosis in Routine Clinical Setting.
Official title: Feasibility of a New Diagnostic Device to Assess Small Intestinal Dysbiosis in Routine Clinical Setting.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Small Intestinal Bacterial Overgrowth
Lead sponsor: Atmo Biosciences Pty Ltd
Sponsor class: INDUSTRY
First posted: 2021-06-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: Inclusion Criteria:

Patients aged over 18 years presenting to the Department of Gastroenterology \& Hepatology at the Princess Alexandra Hospital who require and are booked for an upper gastrointestinal endoscopy as part of the routine diagnostic work up of e.g. otherwise unexplained gastrointestinal symptoms.

Exclusion Criteria:

* Radiation Enteritis
* Pregnancy
* Gastric bezoar
* Swallowing disorders/dysphagia to food or pills
* Obese, with BMI over 35
* Suspected or known strictures of the GI tract
* Fistulas or physiological/mechanical GI obstruction
* GI surgery within the past 3 months
* Diverticultis
* Patients with implantable or portable electro-mechanical medical devices, e.g. pacemakers

Primary outcomes:
measure: Structured Assessment of Gastro-Intestinal Symptoms
timeFrame: 30 minutes prior to endoscopy
measure: Hydrogen fermentation in the small intestine as measured by the Atmo capsule
timeFrame: 30 minutes prior to endoscopy
measure: Small Intestine microbial load as assessed by Jejunal Aspiration and Culture
timeFrame: During endoscpoic procedure
Secondary outcomes:
measure: FOS Breath samples on the day of the endoscopy
timeFrame: Up to 2 hours after the endescopic procedure
measure: Glucose Breath Test
timeFrame: Not earlier than 12 hours after the endoscopic procedure
Other outcomes:
Locations:
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Lucknow
country: India
facility: Sanjay Gandhi Postgraduate Institute of Medical Sciences
state: Uttar Pradesh
Study officials:
affiliation: The University of Queensland
name: Professor Gerald Holtman, MD, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
References: