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

Non-alcoholic Fatty Liver Disease Clinical Trial

Official title:

Could Rifaximin Modify the Pathogenesis of NAFLD? AMulticenter, Randomized, Double-Blind, Placebo-Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02884037
• Other study ID #: R/16.02.80
• Status: Completed
• Phase: N/A
• First received: July 29, 2016
• Last updated: August 9, 2017
• Start date: May 2012
• Est. completion date: October 2016

Study information

• Verified date: August 2017
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease

Intervention

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

Locations

Country	Name	City	State
Egypt	Nasser H Mousa,MD,mousa_medic@yahoo.com. +201227029213	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum ALT	U/l	6 months
Primary	serum endotoxins	EU/ml	6 months
Primary	TLR-4	ng/ml	6 months
Secondary	Fasting Glucose	mg/dl	6 months
Secondary	, Insulin,	µIU/ml	6 months
Secondary	CK-18,TNF-a, IL-6, IL 10	pg/ml	6 months