Rifaximin Modify the Pathogenesis of Non-Alcoholic Fatty Liver Disease (NAFLD)

NCT ID: NCT02884037

Last Updated: 2017-08-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2016-10-31

Brief Summary

In this multicentric, double-blind, randomized,placebo-controlled study, the investigators hypothesized that rifaximin might act on Gram-negative bacteria and intestinal bacterial overgrowth(IBO) thereby inhibiting lipopolysaccharides(LPS)-mediated proinflammatory cytokine production. This work evaluates the efficacy of 6 months administration of rifaximin in NAFLD patients.

Detailed Description

The investigators aimed to study the effect of rifaximin on NASH. 50 patients with biopsy-proven NASH were enrolled in this double-blind, randomized,placebo-controlled study. BMI, AST, ALT, gamma glutamyl transferase (γ-GGT), lipid profile, homeostatic model assessment (HOMA), serum endotoxin, Toll-like receptor 4 (TlR4), interleukin-6 (IL-6), IL-10, tumor necrosis factor-α (TNF-α) and cytokeratin-18 (CK-18) levels were measured before and after a 6 month administration of rifaximin (1100mg/day, 550 mg tablets 1 × 2 before meals).

Conditions

Non-alcoholic Fatty Liver Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1

Rifaxmin group

Rifaximin group 1

Intervention Type: DRUG

Rifaximin: 1100mg/day, 550 mg tablets 1 × 2 before meals

2

placebo group

No interventions assigned to this group

Interventions

Rifaximin group 1

Rifaximin: 1100mg/day, 550 mg tablets 1 × 2 before meals

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. women or men aged 18-65 years.

2. biopsy-proven NASH without or with mild to moderate fibrosis (fibrosis stage 0-3)in the preceding year.

3. persistently abnormal ALT on 2 occasions.

4. participants have provided written informed consent before screening.

5. all patients counseled about the standard of care treatment (e.g., diet andexercise).

6. Strict requirements for weight stability between the time of biopsy and study entry.

Exclusion Criteria

1. Cirrhotic NAFLD (METAVIR stage 4).

2. Combined viral hepatitis B and C infection.

3. increased alcohol intake (>20 g/day) and hypothyroidism.

4. co-existence of another type of biliary tract or pancreatic or liver diseases

5. lactating or pregnant women.

6. allergy to rifamycin or rifaximin.

7. systemic inflammatory conditions (e.g. Connective tissue diseases and inflammatory bowel diseases).

8. bariatric surgery and blind loop.

9. evidence of hepatic decompensation (ascites, hepatic encephalopathy, and varices),

10. history of myocardial infarction and/ or stroke within 6 months.

11. drugs that alter the gut flora e.g. Lactulose, systemic antibiotic, cholestyramine within three months, (l) cancers especially HCC, and (m)patients with renal impairment (estimated GFR <60ml/min/1.73m2).

(n) Major dose change orintiation of biguanides, metformin, thiazolidinediones, insulin, fibrates, statins, and anti-obesity medications within three months before the onset of the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Nasser Mousa

Prof of Tropical Medicine and Hepatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nasser H Mousa,MD,mousa_medic@yahoo.com. +201227029213

Al Mansurah, , Egypt

Countries

Egypt

Other Identifiers

R/16.02.80

Identifier Type: -

Identifier Source: org_study_id