RecruitingACTRN12621000626864

Feasibility of a new diagnostic device to assess small intestinal dysbiosis in the routine clinical setting

Feasibility of the Atmo Gas Sensing Capsule in assessment of small intestinal dysbiosis in adults with unexplained gastrointestinal symptoms in the routine clinical setting


Sponsor

Atmo Biosciences

Enrollment

150 participants

Start Date

Sep 9, 2021

Study Type

Interventional

Conditions

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 (which can be a problem), and to identify people who are likely to respond to therapy. This study aims to compare the data collected from the Atmo gas capsule with conventional breath testing for bacterial imbalance/overgrowth. The results from the study may help show that the capsule is better than either a breath test, or taking samples through endoscopy for determining if someone has Irritable Bowel Syndrome (IBS) or Small Intestinal Bacterial Overgrowth (SIBO), and how likely they are to respond to therapy.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 85 Yearss

Plain Language Summary

Simplified for easier understanding

When there is too much bacteria in the small intestine — a condition sometimes called SIBO (Small Intestinal Bacterial Overgrowth) — it can cause bloating, pain, and other gut symptoms that overlap with irritable bowel syndrome (IBS). Diagnosing this imbalance accurately can be tricky with existing breath tests. This study is testing a new swallowable gas-sensing capsule that travels through the gut and measures gases directly from inside the intestine. The capsule, called the Atmo gas capsule, is compared head-to-head with conventional breath testing and samples taken during endoscopy. Researchers hope the capsule will provide a more accurate and convenient way to detect bacterial imbalances and help predict who is likely to respond to treatment. You may be eligible if you are between 18 and 85 years old and are already scheduled for an upper gastrointestinal endoscopy at the Princess Alexandra Hospital due to unexplained gut symptoms. People with swallowing difficulties, implanted pacemakers, pregnancy, or known narrowings in the gut are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Subjects will be patients 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

Subjects will be patients 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 symptoms. The Atmo ingestible gas sensing capsule is a means of analysing microbiome function at the source of gas production by microbiota. Capsules will be ingested within 30 mins 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. If increased microbial load is determined through culture of aspiration during initial endoscopic procedure, 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. 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.


Locations(1)

Princess Alexandra Hospital - Woolloongabba

QLD, Australia

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ACTRN12621000626864