Using a gas-sensing capsule to diagnose small intestinal dysbiosis.
Feasibility of a New Diagnostic Device to Assess Small Intestinal Dysbiosis in Routine Clinical Setting.
This study is testing a new gas-sensing capsule to see if it can help diagnose small intestinal dysbiosis in patients who are having an upper gastrointestinal endoscopy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Atmo Biosciences Pty Ltd Industry-sponsored |
| Drugs / interventions | Radiation |
| Locations | 2 sites (Woolloongabba, Queensland and 1 other locations) |
| Trial ID | NCT04910815 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility of a new gas-sensing capsule designed to identify small intestinal dysbiosis by measuring the metabolic activity of gut microbiota. Participants will ingest the capsule, which will track gas concentrations during gastrointestinal transit after exposure to fermentable carbohydrates. This method seeks to improve upon traditional breath tests by providing more accurate localization of gas production and overcoming limitations related to breath 'noise'. The study will involve patients scheduled for upper gastrointestinal endoscopy at the Princess Alexandra Hospital.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years with unexplained gastrointestinal symptoms who are scheduled for an upper gastrointestinal endoscopy.
Not a fit: Patients with certain conditions such as radiation enteritis, pregnancy, or significant GI obstructions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate diagnoses of small intestinal bacterial overgrowth, improving treatment options for patients.
How similar studies have performed: Preliminary studies using similar gas-sensing technology have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Woolloongabba, Queensland and 1 other locations
- Princess Alexandra Hospital — Woolloongabba, Queensland, Australia (Recruiting)
- Sanjay Gandhi Postgraduate Institute of Medical Sciences — Lucknow, Uttar Pradesh, India (Not_yet_recruiting)
Study contacts
- Principal investigator: Professor Gerald Holtman, MD, PhD, MBA — The University of Queensland
- Study coordinator: Teressa Hansen, PhD
- Email: Teressa.Hansen@health.qld.gov.au
- Phone: 07 3176 9190
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.