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

Atmo Biosciences

Status: Enrolling

Conditions: Small Intestinal Bacterial Overgrowth

Treatments: Diagnostic Test: Glucose Breath Test; Diagnostic Test: Fructoolifosaccharides (FOS) Breath Test; Procedure: Jejunal Aspiration and culture; Device: Atmo Gas Capsule; Drug: Rifaximin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04910815

72853

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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150 participants in 3 patient groups, including a placebo group

Primary recruitment

Experimental group

Description:

Capsules will be ingested within 30 minutes prior to endoscopy pre- and post-antimicrobial intervention (if the patients has had a treatment) to determine if it can be used to identify increased microbial load through gas detection, and to identify responders to therapy.

Treatment:

Procedure: Jejunal Aspiration and culture

Device: Atmo Gas Capsule

Active SIBO Arm - Rifaximin

Active Comparator group

Description:

If increased microbial load is determined through culture of aspiration during initial endoscopic procedure, randomised administration of Rifaximin (550g) 1 capsule twice a day for 14 days. The post-antimicrobial endoscopic procedure will be conducted at 6 weeks post the start of treatment. These hydrogen concentration results will be compared to the following conventional breath tests in a crossover study design. Immediately after the endoscopic procedure, the patient will undergo a FOS challenge recording hydrogen breath samples for 2 hours in 20 min intervals while they recover from the endoscopic procedure. A standard Glucose breath test will be performed by the patients at home not earlier that 8 hours after the endoscopic procedure.

Treatment:

Diagnostic Test: Glucose Breath Test

Diagnostic Test: Fructoolifosaccharides (FOS) Breath Test

Procedure: Jejunal Aspiration and culture

Drug: Rifaximin

Device: Atmo Gas Capsule

Active SIBO Arm - Placebo

Placebo Comparator group

Description:

If increased microbial load is determined through culture of aspiration during initial endoscopic procedure, randomised administration of placebo capsule twice a day for 14 days. The placebo will be encapsulated maize starch and pregelatinised maize starch. The post-antimicrobial endoscopic procedure will be conducted at 6 weeks post the start of treatment. These hydrogen concentration results will be compared to the following conventional breath tests in a crossover study design. Immediately after the endoscopic procedure, the patient will undergo a FOS challenge recording hydrogen breath samples for 2 hours in 20 min intervals while they recover from the endoscopic procedure. A standard Glucose breath test will be performed by the patients at home not earlier that 8 hours after the endoscopic procedure.

Treatment:

Diagnostic Test: Glucose Breath Test

Diagnostic Test: Fructoolifosaccharides (FOS) Breath Test

Procedure: Jejunal Aspiration and culture

Drug: Placebo

Device: Atmo Gas Capsule