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Trial registered on ANZCTR


Registration number
ACTRN12621000626864
Ethics application status
Approved
Date submitted
24/03/2021
Date registered
25/05/2021
Date last updated
30/11/2023
Date data sharing statement initially provided
25/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of a new diagnostic device to assess small intestinal dysbiosis in the routine clinical setting
Scientific title
Feasibility of the Atmo Gas Sensing Capsule in assessment of small intestinal dysbiosis in adults with unexplained gastrointestinal symptoms in the routine clinical setting
Secondary ID [1] 303769 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
unexplained gastrointestinal symptoms 321260 0
Condition category
Condition code
Oral and Gastrointestinal 319037 319037 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 320077 0
Diagnosis / Prognosis
Intervention code [2] 320337 0
Treatment: Devices
Comparator / control treatment
Glucose Breath Test
Control group
Active

Outcomes
Primary outcome [1] 326944 0
Structured Assessment of Gastro-Intestinal Symptoms
Timepoint [1] 326944 0
on the day of endoscpy
Primary outcome [2] 326945 0
Changes in microbial metabolism as assessed by Atmo capsuleR
Timepoint [2] 326945 0
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.
Primary outcome [3] 326946 0
Glucose Breath Test detects Hydrogen concentrations
Timepoint [3] 326946 0
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 [1] 393194 0
Fructooligosaccharide (FOS) challenge hydrogen breath test
Timepoint [1] 393194 0
After completion of the endoscopic procedure additional samples will be taken every 20 minutes up to 2 hours after the procedure
Secondary outcome [2] 393195 0
Exploratory outcome measure: composite other markers and volatile gases as measured with the Atmo ingestible gas-sensing capsule.
Timepoint [2] 393195 0
During capsule insertion
Secondary outcome [3] 394589 0
Microbial load determination
Timepoint [3] 394589 0
Microbial load is determined through culture of aspiration during initial endoscopic procedure

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The breath test results and the biopsy information will be compared to the data collected by the Atmo Gas Capsule, to help determine if the capsule provides a better result for improved diagnosis. Primary analysis will involve using the Atmo Gas Capsule and breath test to measure hydrogen production in the small bowel to identify those patients with increased microbial load, and where possible to detect changes in hydrogen production after treatment. These results will be benchmarked against the microbial load results obtained from biopsy.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2021
Actual
9/09/2021
Date of last participant enrolment
Anticipated
30/04/2024
Actual
Date of last data collection
Anticipated
30/04/2024
Actual
Sample size
Target
150
Accrual to date
8
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 18994 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 33533 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 33534 0
4102 - Buranda

Funding & Sponsors
Funding source category [1] 308173 0
Commercial sector/Industry
Name [1] 308173 0
Atmo Biosciences
Country [1] 308173 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Atmo Biosciences
Address
Atmo Biosciences
436 Elgar Road
Box Hill VIC 3128
Country
Australia
Secondary sponsor category [1] 308946 0
None
Name [1] 308946 0
Address [1] 308946 0
Country [1] 308946 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308158 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 308158 0
Metro South Human Research Ethics Committee
37 Kent Street
Woolloongabba QLD 4102
Ethics committee country [1] 308158 0
Australia
Date submitted for ethics approval [1] 308158 0
14/01/2021
Approval date [1] 308158 0
10/02/2021
Ethics approval number [1] 308158 0
HREC/2021/QMS/72853

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109738 0
Prof Gerald Holtmann
Address 109738 0
Princess Alexandra Hospital
Department of Gastroenterology & Hepatology
199 Ipswich Rd
Woolloongabba QLD 4102
Country 109738 0
Australia
Phone 109738 0
+61 07 3176 7792
Fax 109738 0
61 07 3176 5111
Email 109738 0
[email protected]
Contact person for public queries
Name 109739 0
Natasha Koloski
Address 109739 0
Princess Alexandra Hospital
Department of Gastroenterology & Hepatology
199 Ipswich Rd
Woolloongabba QLD 4102
Country 109739 0
Australia
Phone 109739 0
+61 0407126897
Fax 109739 0
+61 07 3176 5111
Email 109739 0
[email protected]
Contact person for scientific queries
Name 109740 0
Gerald Holtmann
Address 109740 0
Princess Alexandra Hospital
Department of Gastroenterology & Hepatology
199 Ipswich Rd
Woolloongabba QLD 4102
Country 109740 0
Australia
Phone 109740 0
+61 07 3176 7792
Fax 109740 0
+61 07 3176 5111
Email 109740 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
De-identified individual participant data will not be available for this study. Atmo Biosciences is assessing the diagnostic criteria of the gas capsule which will form core IP for the company.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.