Bovine Immunoglobulin Orally with Modified Doses of Rifaximin for Advanced Cirrhotics in Overt Hepatic Encephalopathy: A Randomized Placebo Control Prospective Clinical Pilot Trial. (BRAIN Trial)

Abstract

Introduction: Overt Hepatic Encephalopathy (OHE) is an integral clinical syndrome in decompensated cirrhosis with significant morbidity. Recurrent hospitalization carries Hospital-acquired infections with threatens risk and further decompensation. Imposes hazards: driving skill, domestic affair, social conduct affecting Global QOL score. Rifaximin, lactulose, Metronidazole and are existing therapy of choice. Several others have been postulated: LOPA, Probiotics, Rivastigmine with moderate efficacy. This clinical trial will evaluate the added efficacy and shorten the course of Rifaximin in clinically OHE. Methods: Overt Hepatic Encephalopathy patients recruited in three groups: A single center: dedicated Psychologist, Dedicated lab; single driving instructor, 3 arm study (groups A, B, and C), n=20 in each. Group A=Rifaximin 550mg BID,BCAA (Branched Chain Amino Acids) x 3 months Group B=Rifaximin 550mg BID,Bovine IG x 3 months Group C=Rifaximin 550mg BID,Bovine IG,BCAA x 3 months Exclusion Criteria: MELD 23 or greater, Uncontrolled DM, SBP Severe Constipation HCC CDAD Active drug or Alcohol use On DAAs therapy PBC PSC Schistosoma AIH Post-Transplant HBV HIV Results: Table 1 Primary Endpoint Global Encephalopathy score Group A median 43% Group B median 63% Group C median 66% Secondary Endpoint impaired Social skill (driving test) Group A median 21% Group B median 33% Group C median 31% Recurrent Hospitalization Time in six months Group A median 65% Group B median 68% Group C median 71% Conclusion: For morbidity in CLF and ACLF with Cognitive and Psychosocial impairment rifaximin is the standard of care. Oral Bovine Immunoglobulin has been used as gut sterilizer and generates Gut specific immune Restitution. This study evaluates adding Oral Bovine immunoglobulin in OHE and concludes that it is not beneficial over the standard of care and not cost effective.907 Figure 1 No Caption available.