O09 A double blind, randomised, placebo-controlled study to assess safety and tolerability of oral enterosorbent Carbalive (Yaq-001) in cirrhotic patients

Abstract

tree-level 2; and 'cooking methods' such as boiling, frying, formed tree-level 3. The associations between particular food intakes and health outcomes (presence of NAFLD and significant fibrosis, diabetes mellitus, hypertension, dyslipidaemia, and cardiovascular events) were determined by logistic regression. Results Individuals with NAFLD consumed significantly higher amount of cereals (as refined rice), fat and edible oils (as animal fat), meat (as red meat), sugar (as refined sugar) and fried foods, and lower amount of vegetables, pulses, nuts, seeds, and milk compared to controls (all P<0.05). Consumption of meat (as red meat), fats (as animal fat), nuts and refined rice was positively associated with both the presence of NAFLD and its severity (significant fibrosis), whereas, consumption of vegetables (as leafy vegetables), fruits, oily seeds, spices, and dried pulses was negatively associated with NAFLD. Fried and boiled food consumption were positively and negatively associated with NAFLD, respectively. Increased consumption of animal fats was associated with diabetes, hypertension, and cardiovascular outcomes, whereas consumption of wholegrain rice was negatively associated with these health-related outcomes. Conclusions Comprehensive evaluation of food intakes using validated FFQ and tree-based approach in a large, well-characterised population-based cases and controls has enabled the identification of specific dietary indicators associated with NAFLD, its severity and the co-morbidity cluster. These findings provide a basis for culturally sensitive advice to prevent the development of NAFLD as well as the design of individualised intervention in those with NAFLD.

The shaping of gut immunity in cirrhosis

“…Yaq-001 is a non-absorbable activated charcoal with a high adsorptive capacity for endotoxins and other products of bacterial metabolism preventing their absorption into the bloodstream. Evidence in BDL rats showed that Yaq-001 was associated with shifts in microbiome composition, attenuated the LPS-induced production of ROS by monocytes, and reductions in liver injury and portal pressure (144). A phase-II clinical study in patients with cirrhosis and diureticsensitive ascites treated with Yaq-001 or placebo for 12 weeks suggested proof of a mechanism that Yak-001 modulated systemic endotoxinemia and inflammation by improving gut inflammation and its permeability (NCT03202498).…”

Novel Therapeutic Approaches in Treatment of Acute-on-Chronic Liver Failure

“…54 While shown to be well tolerated, CARBALIVE dampens systemic inflammation and improves gut permeability. 55 Elsewhere, the observation that alkaline phosphatase, a marker of cholestasis, possesses anti-inflammatory activity through the dephosphorylation of LPS, and thus, its deactivation led to the development of recAP. 56 Thereafter, treatment with recAP in an animal model of ACLF was shown to reduce liver injury, inflammation, and cell death through downregulation of TLR-4 expression.…”

Early Diagnosis and Prevention of Infections in Cirrhosis

“…Yak-001, an orally administered, non-absorbable, synthetic microporous carbon has a high adsorptive capacity for bacterial products, LPS, and pro-inflammatory cytokines. Yak-001 was found to be safe and effective in reducing endotoxemia and inflammatory mediators in patients with decompensated cirrhosis in phase II trials [174]. Recently, obeticholic acid was shown to prevent BT in pre-clinical studies [175].…”

“…Yak-001 was found to be safe and effective in reducing endotoxemia and inflammatory mediators in patients with decompensated cirrhosis in phase-II trials. 174 Recently, obeticholic acid was shown to prevent BT in preclinical studies. 175 While the preliminary data are very encouraging, the clinical utility of these drugs for the prevention of sepsis and consequent organ dysfunction requires further validation.…”