Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000215426
Ethics application status
Approved
Date submitted
16/01/2025
Date registered
26/03/2025
Date last updated
26/03/2025
Date data sharing statement initially provided
26/03/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating the gut-liver axis using a novel gas sensing capsult in cirrhosis and portal hypertension
Scientific title
Evaluating the gut-liver axis using a novel gas sensing capsult in cirrhosis and portal hypertension
Secondary ID [1] 313720 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic liver disease 336319 0
Liver cirrhosis 336320 0
Portal hypertension 336496 0
Condition category
Condition code
Oral and Gastrointestinal 332860 332860 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The burden of chronic liver disease (CLD) continues to rise in Australia. The clinical consequences of advanced CLD occur almost exclusively in the setting of cirrhosis and portal hypertension. Pronounced physiological disturbances including neurohormonal alterations, immune dysfunction, coagulation dysregulation, as well as gut dysbiosis and bacterial translocation leading to systemic inflammation are all contributors to this process. Similarly, intestinal dysmotility worsens between compensated and decompensated liver cirrhosis states. The gut-liver axis is thus an area of considerable interest as a driver of liver disease progression.

We aim to study and compare differences in intestinal motility and intestinal gas profiles amongst patients with compensated and decompensated liver cirrhosis with portal hypertension using a gas sensing capsule (Atmo Biosciences).

The following will occur as part of data collection: (1) Clinical assessment (2) 3-Day Food diary (3) Transient liver elastography (Fibroscan) (4) Peripheral blood collection (frozen as plasma and serum samples) (5) Atmo gas sensing capsule ingestion. Participants will return home with the Atmo Data Receiver and be instructed to remain nil by mouth for 6 hours. The Atmo Data Receiver will be returned once the capsule is passed in the stool.

Data collection will occur during a single study visit which is approximated to last for 1-1.5 hours with the following breakdown: 30mins (clinical assessment), 10 mins (pathology collection), 15 mins (Fibroscan assessment) and 10 mins (capsule ingestion and connection). There will be no further follow up (one time data collection).
Intervention code [1] 330314 0
Diagnosis / Prognosis
Comparator / control treatment
Recruitment for the healthy control cohort will take place in the Austin Health Gastroenterology and Atmo Biosciences Departments. Ten healthy volunteers will be recruited to participate and undergo the same data collection process as described above.
Control group
Active

Outcomes
Primary outcome [1] 340381 0
Intestinal motility
Timepoint [1] 340381 0
Continuous data will be collected by the gas sensing capsule until capsule exit from the body post ingestion. This timepoint varies from patient to patient.
Primary outcome [2] 340550 0
Liver disease severity
Timepoint [2] 340550 0
Single observation session following enrolment
Primary outcome [3] 340728 0
Intestinal gas profiles
Timepoint [3] 340728 0
Continuous data will be recorded from the gas sensing capsule between the period of capsule ingestion to body exit. This timepoint will vary from patient to patient.
Secondary outcome [1] 443912 0
Nutritional assessment
Timepoint [1] 443912 0
72 hours post capsule ingestion
Secondary outcome [2] 444872 0
Systemic inflammation
Timepoint [2] 444872 0
Assessed once at time of capsule ingestion
Secondary outcome [3] 444873 0
Bacterial translocation
Timepoint [3] 444873 0
Assessed once at time of capsule ingestion
Secondary outcome [4] 444874 0
Liver disease severity
Timepoint [4] 444874 0
Assessed once at time of capsule ingestion

Eligibility
Key inclusion criteria
Inclusion criteria (patient cohort):
1. Patients with confirmed liver cirrhosis and portal hypertension
2. Patients with the following liver disease aetiologies: Alcohol (must be abstinent for at least 1 month), viral hepatitis, metabolic-associated fatty liver disease

Inclusion criteria (healthy cohort): individuals without a known diagnosis of cirrhosis or portal hypertension and not meeting exclusion criteria.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. under 18 years of age or unable/unwilling to provide consent
2. patients already on NSBB therapy
3. BMI >35
4. diabetes mellitus with known gastroparesis or autonomic dysfunction
5. pregnancy, swallowing disorders/dysphagia to food or pills,
6. radiation enteritis
7. diverticulitis
8. suspected or known strictures of the GI tract
9. fistulas or physiological/mechanical GI obstruction
10. GI surgery within the past 3 months
11. Suspected obscure GI bleeding
12. Gastric bezoar
13. Implantable/portable electro-mechanical medical devices e.g. pacemakers.
14. patients taking medications that may lower portal pressure (i.e. terlipressin infusion) or that may have a direct effect on intestinal gas profiles (lactulose, antibiotics with the exception of rifaximin) within 2 weeks
15. liver disease aetiologies other than those described in inclusion criteria
16. transjugular portosystemic shunt (TIPS) in situ with prophylactic rifaximin

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
23/05/2024
Date of last participant enrolment
Anticipated
30/11/2025
Actual
Date of last data collection
Anticipated
30/01/2026
Actual
Sample size
Target
30
Accrual to date
9
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318185 0
Government body
Name [1] 318185 0
Government body - National Health and Medical Research Council (NHMRC)
Country [1] 318185 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 320573 0
None
Name [1] 320573 0
Address [1] 320573 0
Country [1] 320573 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316837 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 316837 0
Ethics committee country [1] 316837 0
Australia
Date submitted for ethics approval [1] 316837 0
19/01/2024
Approval date [1] 316837 0
22/05/2024
Ethics approval number [1] 316837 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139158 0
Dr Beverly Rodrigues
Address 139158 0
Department of Gastroenterology and Hepatology. Level 8 Harold Stokes Building, Austin Hospital. 145 Studley Road Heidelberg VIC 3084
Country 139158 0
Australia
Phone 139158 0
+61 425447759
Fax 139158 0
Email 139158 0
[email protected]
Contact person for public queries
Name 139159 0
Beverly Rodrigues
Address 139159 0
Department of Gastroenterology and Hepatology. Level 8 Harold Stokes Building, Austin Hospital. 145 Studley Road Heidelberg VIC 3084
Country 139159 0
Australia
Phone 139159 0
+61 425447759
Fax 139159 0
Email 139159 0
[email protected]
Contact person for scientific queries
Name 139160 0
Beverly Rodrigues
Address 139160 0
Department of Gastroenterology and Hepatology. Level 8 Harold Stokes Building, Austin Hospital. 145 Studley Road Heidelberg VIC 3084
Country 139160 0
Australia
Phone 139160 0
+61 425447759
Fax 139160 0
Email 139160 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24448Ethical approval    Atmo_HREC Approval.pdf
24501Informed consent form    Master PICF v3_22Aug2024_clean.docx



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.