Overview

Microbial Resistance of Rifaximin in Hepatic Encephalopathy

Status:
Completed

Trial end date:
2019-06-01

Target enrollment:
0

Participant gender:
All

Summary

Aims and Objectives: To determine the safety and efficacy of rifaximin plus lactulose as secondary prophylaxis of HE compared to lactulose alone. To evaluate the effect of long-term administration of rifaximin on development of resistant mutants and investigating its correlation with its efficacy. Methods: An open label parallel, prospective interventional study was conducted. One hundred patients experienced at least one attack of hepatic encephalopathy were included in the study. Patients were randomly allocated either to receive rifaximin plus lactulose or lactulose alone for 6 months. Conn score, Model of End stage Liver Disease (MELD) score, asterixis grade, complete blood count (CBC), liver function tests, kidney function tests, urine and stool analysis and abdominal ultrasonography were compared in both groups. The primary efficacy endpoint was the time to the first breakthrough. The secondary efficacy endpoint was the time to the first hospitalization involving HE. Safety assessment was done by reporting any adverse events, serious adverse events and by repeating biochemical evaluation every 2 weeks. Determination of the minimum inhibitory concentration (MIC) of rifaximin for lactose fermenter isolates was done for the entire patients before starting treatment and at the end of treatment.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

National Hepatology & Tropical Medicine Research Institute

Treatments:

Rifaximin

Criteria

Inclusion Criteria:

- The inclusion criteria

1. cirrhosis due to HCV infection

2. age 18 to 75 years,

3. experiencing at least one episode of OHE,

4. MELD score ≤ 25

Exclusion Criteria:

1. Patients with neurological or communication problems,

2. hepatocellular carcinoma

3. diabetes mellitus

4. active infection

5. serum creatinine > 2 mg/dl, Hg < 8 g/dL, serum Na < 125 mmol/L or serum K < 2.5 mmol/L
.

6. Patients with previous intake of rifaximin as prophylaxis or any antibiotic within the
last month