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Completed

NCT Number: NCT02884037

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • women or men aged 18-65 years.
  • biopsy-proven NASH without or with mild to moderate fibrosis (fibrosis stage 0-3)in the preceding year.
  • persistently abnormal ALT on 2 occasions.
  • participants have provided written informed consent before screening.
  • all patients counseled about the standard of care treatment (e.g., diet andexercise).
  • Strict requirements for weight stability between the time of biopsy and study entry.

Exclusion criteria

  • Cirrhotic NAFLD (METAVIR stage 4).
  • Combined viral hepatitis B and C infection.
  • increased alcohol intake (>20 g/day) and hypothyroidism.
  • co-existence of another type of biliary tract or pancreatic or liver diseases
  • lactating or pregnant women.
  • allergy to rifamycin or rifaximin.
  • systemic inflammatory conditions (e.g. Connective tissue diseases and inflammatory bowel diseases).
  • bariatric surgery and blind loop.
  • evidence of hepatic decompensation (ascites, hepatic encephalopathy, and varices),
  • history of myocardial infarction and/ or stroke within 6 months.
  • 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.

Treatment and study plan

Rifaximin group 1

Drug

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

Primary outcomes

  1. serum ALT

    Time frame: 6 months

    U/l

  2. serum endotoxins

    Time frame: 6 months

    EU/ml

  3. TLR-4

    Time frame: 6 months

    ng/ml

Secondary outcomes

  1. Fasting Glucose

    Time frame: 6 months

    mg/dl

  2. , Insulin,

    Time frame: 6 months

    μIU/ml

  3. CK-18,TNF-α, IL-6, IL 10

    Time frame: 6 months

    pg/ml

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Aug 30, 2016
Registry last updated
Aug 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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