The effect of Rifaximin (an antibiotic drug commonly used in liver failure patients) and standard medical therapy vs standard medical therapy alone on myosteatosis (fat deposition in abdominal muscles), in patients with decompensated cirrhosis- a randomized controlled trial

Not Applicable

• Conditions: Health Condition 1: K746- Other and unspecified cirrhosis ofliver

• Registration Number: CTRI/2024/07/069984
• Lead Sponsor: PGIMER, CHANDIGARH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1) Patients of decompensated cirrhosis of any etiology

2) Evidence of myosteatosis on CT

Exclusion Criteria

1. Patients with CTP score more than 10.

2. Patient with acute on chronic liver failure (ACLF)

3. Patients with active malignancy, hepatocellular carcinoma, and end-stage renal

disease.

4. Patients having prior study enrolment or enrolment in another conflicting

study.

5. Patients, not willing to participate in the study.

6. Individuals who have engaged in other clinical trials within the preceding 3 months.

7. Patients who have active evidence of infection.

8. Patients who had acute organic brain disease in the past 6 months.

9. Individuals experiencing severe hemodynamic instability, significant heart disease,

pronounced bradycardia, or resting tachycardia.

10. Renal failure patients (creatinine clearance rate 60 mL/min/1.73 m2).

11. Patients with severe cognitive impairment, overt hepatic encephalopathy, or patients

who had a physical disability.

12. Patients with HIV

13. Pregnancy

14. Post liver transplant patients

15. Exposure to Rifaximin in the previous 12 weeks

16. Known hypersensitivity to Rifaximin

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess improvement in myosteatosis between RIFAXIMIN and SMT vs SMT alone group as evident in repeat NCCT abdomenTimepoint: 24 weeks

Secondary Outcome Measures

Name	Time	Method
1) Improvement in overall health related quality of life using FSS and HDQLI <br/ ><br>2) Changes in total Body fat and visceral body fat as evident from bioimpedance analysis <br/ ><br>3)Improvement in cognitive function using MOCA <br/ ><br>5)Improvement in anthropometric measurements like BMI, Handgrip strength, Chair Stand Test and Balance Test <br/ ><br>4)Incidence in adverse events between two groups. <br/ ><br>5) Death and Hospitalization <br/ ><br>Timepoint: 24 weeks