None listed
Conditions
Brief summary
Single site exploratory prospective cohort study involving twenty patients compared against ten healthy controls. Primary endpoint to is 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. We hypothesize that small bowel motility and bacterial metabolism are significantly altered in the setting of portal hypertension, and dynamically change with increasing portal pressure and severity of liver disease. We anticipate that there will be a correlation between intestinal gas profiles, gut transit times and markers of inflammation and/or immune dysfunction.
Interventions
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).
Sponsors
Eligibility
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.
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