Branch Chain Amino Acids vs. Rifaximin in Patients With Cirrhosis for Secondary Prophylaxis of Hepatic Encephalopathy: Double-blind Placebo-controlled Multicentric Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Objectives: * To assess the 1st breakthrough episode of HE during 6months in BCAA vs rifaximin groups as ideal secondary prophylaxis in HE. Methodology * Double-blind placebo-controlled double-dummy randomized trial of BCAA supplementation vs rifaximin as the ideal second-line therapy in patients with cirrhosis who have recovered from an episode of OHE. Expected Outcome * Ideal second line agent HE prophylaxis (rifaximin or BCAA) following 1st line lactulose is unclear in an Indian context where dysbiosis and sarcopenia are prevalent, and cost of therapy needs to be optimized. * Optimal HE management prevents recurrence episodes of HE, and improves prognosis, neurocognitive function, and overall health-related quality of life(HRQOL). * Creation of a management algorithm based deductive models incorporating etiology and severity of liver disease, cognitive performance, sarcopenia, and ammonia, and neuropsychiatric impact of using BCAA vs Rifaximin will be created.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Cirrhosis defined by standard clinical, ultrasonographic findings and/or histological criteria. Cirrhosis of any etiology may be included. However, patients with cirrhosis due to autoimmune hepatitis must be on stable corticosteroid doses for ≥3-month period before study inclusion; those with viral hepatitis, must similarly be on anti-viral therapy with controlled viremia or with SVR.

• Any gender

• Discharged from the hospital following an episode of overt hepatic encephalopathy.

• Participants able to give informed consent

Locations
Other Locations
India
PGIMER
RECRUITING
Chandigarh
Contact Information
Primary
Madhumita Premkumar
drmadhumitap@gmail.com
+9101722754777
Time Frame
Start Date: 2025-02-01
Estimated Completion Date: 2027-08
Participants
Target number of participants: 336
Treatments
Experimental: A1=Experimental:
Drug: Oral BCAA + Rifaximin placebo + Lactulose ( Oral BCAA 15 gm in once daily dose With Lactulose for 12 weeks)
Experimental: A2= Experimental:
Drug: Rifaximin+ BCAA Placebo + Lactulose ( Oral Rifaximin 550 mg twice daily daily + Lactulose therapy for 12 weeks)
Related Therapeutic Areas
Sponsors
Collaborators: Indian Council of Medical Research
Leads: Post Graduate Institute of Medical Education and Research, Chandigarh

This content was sourced from clinicaltrials.gov