None listed
Conditions
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 (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.
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 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 interv
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.
Sponsors
Atmo Biosciences
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
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 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
Outcome results
None listed