NCT02884037

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

August 11, 2017

Status Verified

August 1, 2017

Enrollment Period

3 years

First QC Date

July 29, 2016

Last Update Submit

August 9, 2017

Conditions

Non-alcoholic Fatty Liver Disease

Keywords

NAFLDRifaximinEndotoxin and Homeostatic Model Assessment

Outcome Measures

Primary Outcomes (3)

  • serum ALT

    U/l

    6 months

  • serum endotoxins

    EU/ml

    6 months

  • TLR-4

    ng/ml

    6 months

Secondary Outcomes (3)

  • Fasting Glucose

    6 months

  • , Insulin,

    6 months

  • CK-18,TNF-α, IL-6, IL 10

    6 months

Study Arms (2)

1

Rifaxmin group

Drug: Rifaximin group 1

2

placebo group

Interventions

Rifaximin group 1DRUG

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

1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

In this multicentric, double-blind, randomized,placebo-controlled study, we enrolled consecutively 1072 participants with hepatitis irrespective to their etiologies referred to the Tropical Medicine and Internal Medicine Departments (Mansoura University), Tropical Medicine Department (Zagazig University), and Internal Medicine and Endemic Diseases and Gastroenterology Departments (Aswan University)from May 2012 to October 2016. All participants underwent to the following appraisal: physical and biochemical examination, complete history taking, abdominal ultrasound, and percutaneous ultrasound liver biopsy.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof of Tropical Medicine and Hepatology

Study Record Dates

First Submitted

July 29, 2016

First Posted

August 30, 2016

Study Start

May 1, 2012

Primary Completion

May 1, 2015

Study Completion

October 1, 2016

Last Updated

August 11, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)