UnknownNot Applicable

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

Australia, India150 participantsStarted 2021-07-14

Plain-language 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

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Structured Assessment of Gastro-Intestinal Symptoms

Timeframe: 30 minutes prior to endoscopy

Hydrogen fermentation in the small intestine as measured by the Atmo capsule

Timeframe: 30 minutes prior to endoscopy

Small Intestine microbial load as assessed by Jejunal Aspiration and Culture

Timeframe: During endoscpoic procedure

Trial details

NCT IDNCT04910815

SponsorAtmo Biosciences Pty Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06-01

Contact for this trial

Teressa Hansen, PhD

07 3176 9190 Teressa.Hansen@health.qld.gov.au

View on ClinicalTrials.gov More Small Intestinal Bacterial Overgrowth trials

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Structured Assessment of Gastro-Intestinal Symptoms

Timeframe: 30 minutes prior to endoscopy

Hydrogen fermentation in the small intestine as measured by the Atmo capsule

Timeframe: 30 minutes prior to endoscopy

Small Intestine microbial load as assessed by Jejunal Aspiration and Culture

Timeframe: During endoscpoic procedure