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

Not Applicable

Recruiting

• Conditions: unexplained gastrointestinal symptoms; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12621000626864
• Lead Sponsor: Atmo Biosciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-25
• Last Update Posted: 12 December 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Structured Assessment of Gastro-Intestinal Symptoms [ on the day of endoscpy];Changes in microbial metabolism as assessed by Atmo capsuleR<br><br>[ Capsules will be ingested within 30 mins prior to endoscopy pre and post anti microbial intervention and will collect concentration measures for the duration of the capsules transit through the gastrointestinal tract, on average 24 hours but up to 5 days.<br>];Glucose Breath Test detects Hydrogen concentrations[ The patients will be asked to perform (not earlier than at least 8 hours after the endoscopic procedure) at home a standard glucose test consistent with the established clinical protocol for the diagnosis of SIBO]

Secondary Outcome Measures

Name	Time	Method
Fructooligosaccharide (FOS) challenge hydrogen breath test[ After completion of the endoscopic procedure additional samples will be taken every 20 minutes up to 2 hours after the procedure];Exploratory outcome measure: composite other markers and volatile gases as measured with the Atmo ingestible gas-sensing capsule.[ During capsule insertion];Microbial load determination[ Microbial load is determined through culture of aspiration during initial endoscopic procedure]