Status:
RECRUITING
Feasibility of a New Diagnostic Device to Assess Small Intestinal Dysbiosis in Routine Clinical Setting.
Lead Sponsor:
Atmo Biosciences Pty Ltd
Conditions:
Small Intestinal Bacterial Overgrowth
Eligibility:
All Genders
18-60 years
Phase:
NA
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 to assess smal...
Detailed 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 b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04910815
Start Date
July 14 2021
End Date
August 1 2024
Last Update
January 30 2024
Active Locations (2)
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1
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
2
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, Uttar Pradesh, India, 226014,