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

Completed

• Conditions: Non-alcoholic Fatty Liver Disease
• Interventions: Drug: Rifaximin group 1

• Registration Number: NCT02884037
• Lead Sponsor: Mansoura University

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).

Study Timeline

• Study Start: 2012-05
• Primary Completion: 2015-05
• Study First Submitted: 2016-07-29
• Study First Submitted QC: 2016-08-25
• Study First Posted: 2016-08-30
• Study Completion: 2016-10
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-09
• Last Update Posted: 2017-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Rifaximin group 1	Rifaxmin group

Primary Outcome Measures

Name	Time	Method
serum ALT	6 months	U/l
serum endotoxins	6 months	EU/ml
TLR-4	6 months	ng/ml

Secondary Outcome Measures

Name	Time	Method
CK-18,TNF-α, IL-6, IL 10	6 months	pg/ml
Fasting Glucose	6 months	mg/dl
, Insulin,	6 months	μIU/ml

Trial Locations

Locations (1)

Nasser H Mousa,MD,mousa_medic@yahoo.com. +201227029213; 🇪🇬 Mansoura, Egypt