Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000934842p
Ethics application status
Submitted, not yet approved
Date submitted
18/11/2020
Date registered
16/07/2021
Date last updated
16/07/2021
Date data sharing statement initially provided
16/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Measuring intestinal gases using the Atmo Gas Capsule in patients with inflammatory bowel disease
Scientific title
Intestinal Gas Measurements using the Atmo Gas Capsule in Inflammatory Bowel Disease
Secondary ID [1] 302822 0
Nil known
Universal Trial Number (UTN)
U1111-1261-3788
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
inflammatory bowel disease 319788 0
Condition category
Condition code
Oral and Gastrointestinal 317717 317717 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Atmo Gas Capsule is a novel swallowed capsule device sponsored by Atmo Biosciences. It is designed to measure the levels of certain gases eg. oxygen, carbon dioxide, hydrogen, methane, as the capsule passes through the bowels. The pattern of gas concentrations will reflect the microbiome composition of the bowels. This is an explorative study in 5 patients with active inflammatory bowel disease. Participants will be patients of at least 18 years old who are to be newly commenced on treatment of their active inflammatory bowel disease. Due to Crohn's disease being associated with an increased risk of intestinal strictures and possible capsule retention within the body, patients with Crohn's disease will need to have had a magnetic resonance enterography (MRE) scan within the past 3-6 months demonstrating no strictures, or first demonstrate the ability to pass a wax capsule containing a radiofrequency identifier. The wax capsule will dissolve and not cause harm even if it fails to pass through the bowels. An externally held radiofrequency detector can be used to see whether the wax capsule remains in the body. If the wax capsule is not passed within 5 days, these patients will not proceed with the remainder of the study. Participants with ulcerative colitis will not need to be first screened using a wax capsule as ulcerative colitis does not predispose patients to intestinal strictures. Participants allowed to proceed with the Atmo Gas Capsule will then fast overnight before presenting to the Department of Gastroenterology at Concord Hospital where they will swallow one Atmo Gas Capsule under supervision, before fasting for a further 6 hours. This will be repeated in 8-12 weeks following treatment of their active inflammatory bowel disease. In each case, once the Atmo Gas Capsule is swallowed, it transmits information about individual gases (hydrogen, carbon dioxide, oxygen and methane) and temperature every 5 minutes to an external receiver connected to a mobile phone device (both provided by Atmo Biosciences). Data recording will then be ceased once the capsule has been passed from the body (confirmed visually in the toilet bowl or signal loss from the capsule after a bowel movement). Participants will need to keep the data receiver for the gas capsule within 1.5 metres of their body until passage of the capsule has been confirmed. The Atmo Gas Capsules are single-use and will not be collected from the toilet bowl. The data are sent to the Cloud and analysed against a pre-trial calibration of the individual capsules. The pre-trial calibration is run in a controlled environment with gas mixtures created using a mass flow controller.
From this study we hope to see if and how the pattern of intestinal gas composition will change as the inflammatory bowel disease activity changes, and if the pattern of gas will predict response to treatment of active inflammatory bowel disease.
Standard care for treating active inflammatory bowel disease will depend on the participants' gastroenterologist. This might include biologic medications, nutritional interventions, blood tests, scans, or endoscopy. There is no single guideline that will determine the treatment used. In each case, participation in this study will not alter any medical management planned for participants had they not been involved in this study.
Intervention code [1] 319101 0
Treatment: Devices
Comparator / control treatment
Each participant will act as their own control as we will use the Atmo Gas Capsule to measure intestinal gases before and after treatment of their inflammatory bowel disease.
Control group
Active

Outcomes
Primary outcome [1] 325764 0
The Atmo Gas Capsule will be used to measure intestinal gas composition before and after treatment of active inflammatory bowel disease. Gas composition will reflect the microbiome composition in the bowels and hopefully provide gas signals which can be correlated to active versus inactive/less active inflammatory bowel disease. The Atmo Gas Capsule will transmit data to a detector connected to a mobile phone to be kept within 1.5 metres of the participant until the Atmo Gas Capsule is passed out of the body.
Timepoint [1] 325764 0
Participants will take the Atmo Gas Capsule shortly (likely within 1-2 weeks) before commencing treatment of their active inflammatory bowel disease, and then again after 8-12 weeks, by which point they would have completed initial treatment of their active inflammatory bowel disease. There is no exact duration post-completion of initial treatment of inflammatory bowel disease when the second Atmo Gas Capsule measurement is to be made, but this will likely be within 4 weeks, and certainly will be 8-12 weeks following the initial Atmo Gas Capsule measurement.
Secondary outcome [1] 389061 0
Inflammatory bowel disease activity assessed as per standard care with clinical assessment, endoscopy, serum inflammatory markers, and/or faecal calprotectin will be measured before and after treatment of active inflammatory bowel disease. There will be no single guideline used to assess disease activity. However greater symptom burden, higher faecal calprotectin, and higher serum inflammatory markers will indicate more severe disease activity. Endoscopy can indicate disease activity by the degree of disease extension and the severity of bowel lesions and complications.
Timepoint [1] 389061 0
Similar to the measurements using the Atmo Gas Capsule, measurement of inflammatory bowel disease activity will be performed before and after initial treatment of the active inflammatory bowel disease. The initial treatment will take 8-12 weeks. These measurements of disease activity will likely be within 4 weeks of start and finish of initial treatment.

Eligibility
Key inclusion criteria
Participants being newly commenced on treatment of active inflammatory bowel disease, and are 18 years or older in age
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Concurrent irritable bowel syndrome
Previous gastrointestinal surgery
Probiotics use
Indeterminate colitis
Implantable devices such as a pacemaker
Suspected or known strictures
Patients potentially requiring MRI after the capsule has been ingested
Pregnancy
Radiation enteritis
Gastric bezoar
Swallowing disorders / dysphagia to food or pills
Obese, with BMI over 35
Fistulas, or physiological/mechanical gastrointestinal obstruction
Diverticulitis

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2021
Actual
Date of last participant enrolment
Anticipated
30/11/2021
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
5
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18059 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 32037 0
2139 - Concord

Funding & Sponsors
Funding source category [1] 307245 0
Commercial sector/Industry
Name [1] 307245 0
Atmo Biosciences
Country [1] 307245 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Atmo Biosciences
Address
Ground Floor, 436 Elgar Road
Box Hill
Victoria 3128
Australia
Country
Australia
Secondary sponsor category [1] 307863 0
None
Name [1] 307863 0
Address [1] 307863 0
Country [1] 307863 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 307340 0
Bellberry HREC
Ethics committee address [1] 307340 0
123 Glen Osmond Road
Eastwood SA 5063
Australia
Ethics committee country [1] 307340 0
Australia
Date submitted for ethics approval [1] 307340 0
04/05/2021
Approval date [1] 307340 0
Ethics approval number [1] 307340 0

Summary
Brief summary
This is an exploratory study testing the Atmo Gas Capsule in 5 patients aged 18 years or over with active inflammatory bowel disease. The Atmo Gas Capsule is a novel swallowed capsular technology which measures gas concentrations (eg. oxygen, carbon dioxide, hydrogen, methane) in the gastrointestinal tract and sends data to an external receiver kept within 1.5 metres of the body. Intestinal gas composition is expected to reflect the gut microbiome composition. We will first exclude any intestinal strictures in patients with Crohn’s disease as strictures might increase the risk of capsule retention within the bowels. This will be done by demonstrating no strictures on a magnetic resonance enterography (MRE) scan within the past 3-6 months, or by first successfully passing a swallowed wax capsule containing a radiofrequency identifier. An externally held radiofrequency detector will be used to detect whether the wax capsule has passed out of the body after 5 days. If it does not pass within 5 days, the wax capsule will melt by itself and cause no harm, but these patients will not proceed with the study. Patients with Crohn’s disease who have a recent MRE with no strictures or have successfully passed the wax capsule will be able to proceed with the rest of the study. Patients with ulcerative colitis will not need this initial screening for strictures as ulcerative colitis does not predispose patients to intestinal strictures. Measurements will then be taken using the Atmo Gas Capsule before and after (8-12 weeks later) initial treatment of active inflammatory bowel disease and correlated with inflammatory bowel disease activity before and after treatment assessed clinically and by various means such as serum inflammatory markers, faecal calprotectin, or endoscopy. This will allow us to see if certain intestinal gas patterns can be correlated to disease activity and also see if gas patterns can help predict response to treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106894 0
Prof Rupert Leong
Address 106894 0
Department of Gastroenterology and Liver Services
Concord Repatriation General Hospital
Hospital Road, Concord, NSW 2139
Australia
Country 106894 0
Australia
Phone 106894 0
+61 2 9767 6111
Fax 106894 0
Email 106894 0
[email protected]
Contact person for public queries
Name 106895 0
Dr Karen Waller
Address 106895 0
Department of Gastroenterology and Liver Services
Concord Repatriation General Hospital
Hospital Road, Concord, NSW 2139
Australia
Country 106895 0
Australia
Phone 106895 0
+61 2 9767 6111
Fax 106895 0
Email 106895 0
[email protected]
Contact person for scientific queries
Name 106896 0
Dr Karen Waller
Address 106896 0
Department of Gastroenterology and Liver Services
Concord Repatriation General Hospital
Hospital Road, Concord, NSW 2139
Australia
Country 106896 0
Australia
Phone 106896 0
+61 2 9767 6111
Fax 106896 0
Email 106896 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
This is an exploratory study in only 5 patients. Individual data will not be shared as it may be too easy to identify individuals. Rather, pooled de-identified patient data may be published.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9796Study protocol    380959-(Uploaded-30-06-2021-19-49-59)-Study-related document.doc
9797Informed consent form    380959-(Uploaded-30-06-2021-19-50-40)-Study-related document.doc



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.