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Antibiotic

Rifaximin for Hepatic Encephalopathy

Phase 3
Waitlist Available
Led By Ronnie Fass, MD
Research Sponsored by MetroHealth Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Study Summary

This trial will study the effects of Rifaximin on patients with Cirrhosis who have Small Intestinal Bacterial Overgrowth (SIBO) and Covert Hepatic Encephalopathy (CHE).

Eligible Conditions
  • Minimal Hepatic Encephalopathy
  • Small Intestinal Bacterial Overgrowth
  • Gastroparesis
  • Liver Cirrhosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Comparing the effects of Rifaximin on patients with covert hepatic encephalopathy (CHE) and SIBO using neuropsychometric test (NST) and glucose hydrogen breath test (BT) after 8 weeks of Rifaximin.
Secondary outcome measures
Improvement in small bowel motility in subjects taking Rifaximin

Side effects data

From 2014 Phase 4 trial • 222 Patients • NCT01842581
19%
Hepatic encephalopathy
17%
Oedema peripheral
16%
Constipation
14%
Nausea
14%
Fatigue
12%
Insomnia
11%
Urinary tract infection
10%
Pruritus generalised
8%
Muscle spasms
7%
Abdominal pain
7%
Decreased appetite
6%
Ascites
6%
Dyspnoea
6%
Headache
5%
Cough
5%
Renal failure acute
5%
Vomiting
5%
Asthenia
5%
Anaemia
5%
Anxiety
4%
Jaundice
4%
Diarrhoea
3%
Abdominal distension
3%
Cellulitis
3%
Depression
2%
Bronchitis
2%
Peritonitis bacterial
2%
Hyperkalaemia
2%
Liver transplant
1%
Acute respiratory failure
1%
Gastrointestinal haemorrhage
1%
Haematemesis
1%
Fluid overload
1%
Hyperglycaemia
1%
Non-cardiac chest pain
1%
Herpes zoster
1%
Cerebrovascular accident
1%
Thrombocytopenia
1%
Pneumococcal bacteraemia
1%
Pneumonia
1%
Sepsis
1%
Septic shock
1%
Craniocerebral injury
1%
Hepatic failure
1%
Hepatitis
1%
Hepatorenal syndrome
1%
Toxic encephalopathy
1%
Subarachnoid haemorrhage
1%
Anxiety disorder
1%
Suicidal ideation
1%
Calculus ureteric
1%
Oliguria
1%
Renal failure
1%
Pleural effusion
1%
Flatulence
1%
Cardiac failure congestive
1%
Haematochezia
1%
Upper gastrointestinal haemorrhage
1%
Chest pain
1%
Systemic inflammatory response syndrome
1%
Chronic hepatic failure
1%
Subdural haematoma
1%
Dehydration
1%
Alcoholic seizure
1%
Hypovolaemic shock
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rifaximin 550 mg BID
Rifaximin 550 mg BID + Lactulose

Trial Design

1Treatment groups
Experimental Treatment
Group I: RifaximinExperimental Treatment1 Intervention
Rifaximin 550 mg by mouth twice daily for eight weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rifaximin
2005
Completed Phase 4
~3120

Find a Location

Who is running the clinical trial?

MetroHealth Medical CenterLead Sponsor
115 Previous Clinical Trials
21,639 Total Patients Enrolled
Ronnie Fass, MD5.02 ReviewsPrincipal Investigator - Metrohealth Medical Center/Case Western Reserve University
MetroHealth Medical Center
10 Previous Clinical Trials
419 Total Patients Enrolled
~0 spots leftby Jun 2025
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