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RECRUITING

NCT06538077

PHASE4

BCAA vs. Rifaximin in Patients With Cirrhosis for Secondary Prophylaxis of HE

Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

View on ClinicalTrials.gov

Summary

Rationale * Patients who recover from an episode of overt HE(OHE) are at risk of recurrent episodes of HE and persistent minimal hepatic encephalopathy, impacting their daily functioning and mental health. * A multicentric pan-India team will evaluate the role of oral branched-chain amino acids (BCAA) vs Rifaximin as secondary prophylaxis following overt HE as compared with improvement in cognitive function. Novelty: * This study is intended to investigate the role of BCAA vs rifaximin as the ideal second-line therapy for HE management, recurrence, and overall health, including cognitive function, depression and anxiety. * The head-to-head comparison of BCAA+lactulose+ pill-placebo vs rifaximin+ lactulose+ powder-placebo ensures minimization of bias and has adequate power to determine rates of recurrence, 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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

336

Start Date

2025-02-01

Completion Date

2027-08

Last Updated

2025-06-10

Healthy Volunteers

Conditions

Hepatic Encephalopathy Decompensated Cirrhosis Minimal Hepatic Encephalopathy

Interventions

DRUG

Oral Branched chain Amino acid

The active drug BCAA supplement will be dispensed in a dose of 15 gm once daily x 12 weeks

DRUG

Rifaximin 550 MG

Active drug rifaximin will be dispensed in a dose of 550mg twice daily x 12 weeks

DRUG

Lactulose

Both groups will be treated with will be treated with 30-60 ml lactulose three times a day to ensure passage of 2-3 semisoft stools per day

DRUG

Placebo for BCAA

A placebo comparator of 15 gm of skimmed milk powder will be used.

DRUG

Placebo for Rifaximin 550mg

Identical placebo sugar pills will be used as a placebo.

Inclusion Criteria: 1. 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. 2. Any gender 3. Discharged from the hospital following an episode of overt hepatic encephalopathy. 4. Participants able to give informed consent Exclusion Criteria: 1. Subjects with active bacterial or fungal infection 2. Subjects with active or very recent gastrointestinal bleeding in the last 2 weeks. 3. Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy according to the West-Haven classification. 4. Conditions that can impact interpretation of cognitive function: i) Untreated viremic hepatitis C virus infection ii) Established neurological/degenerative disorders iii) Patient undergoing active alcohol withdrawal treatment Iv) Patient is intoxicated or under the influence of illicit drugs as per clinician assessment V) Treatment with antipsychotics or other psychotropic drugs with sedative effects 5. Patients with active hepatocellular carcinoma or history of hepatocellular carcinoma that is in remission for less than six months. 6. Patients with a history of significant extrahepatic disease with impaired short-term prognosis, including: i) Congestive heart failure New York Heart Association Grade III/IV or ejection fraction\<30% ii) COPD: GOLD \>2, ii) Chronic kidney disease with serum creatinine \>2mg/dL or under renal replacement therapy. 7. Patients with current extra hepatic malignancies, including solid tumours and hematologic disorders. 8. Patients with MELD\>20 9. Patients with mental incapacity, or those unlikely to survive 12 weeks or any other reason considered by the investigator precluding adequate understanding, cooperation, or compliance in the study activities. 10. Patients with TIPS shunt in situ 11. Pregnancy (urine pregnancy test at inclusion) 12. Refusal or inability to give informed consent

Locations (1)

PGIMER

Chandigarh, India

Clinical Research Directory

BCAA vs. Rifaximin in Patients With Cirrhosis for Secondary Prophylaxis of HE

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (1)