← Back to Search

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

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

Muscle spasms

Abdominal pain

Decreased appetite

Ascites

Dyspnoea

Headache

Cough

Renal failure acute

Vomiting

Asthenia

Anaemia

Anxiety

Jaundice

Diarrhoea

Abdominal distension

Cellulitis

Depression

Bronchitis

Peritonitis bacterial

Hyperkalaemia

Liver transplant

Acute respiratory failure

Gastrointestinal haemorrhage

Haematemesis

Fluid overload

Hyperglycaemia

Non-cardiac chest pain

Herpes zoster

Cerebrovascular accident

Thrombocytopenia

Pneumococcal bacteraemia

Pneumonia

Sepsis

Septic shock

Craniocerebral injury

Hepatic failure

Hepatitis

Hepatorenal syndrome

Toxic encephalopathy

Subarachnoid haemorrhage

Anxiety disorder

Suicidal ideation

Calculus ureteric

Oliguria

Renal failure

Pleural effusion

Flatulence

Cardiac failure congestive

Haematochezia

Upper gastrointestinal haemorrhage

Chest pain

Systemic inflammatory response syndrome

Chronic hepatic failure

Subdural haematoma

Dehydration

Alcoholic seizure

Hypovolaemic shock

100%

80%

60%

40%

20%

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

Do I qualify?Apply below to find out

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project have an age limit?

"The age requirement for this trial is 18-89. There are a total of 147 studies involving people younger than 18 and 548 with elderly patients."

Answered by AI

Are people with the required medical condition still able to join this trial?

"That is correct, the clinical trial detailed on clinicaltrials.gov is currently looking for 20 participants at 1 location. The listing was first posted on September 15th, 2021 and edited most recently on November 23rd, 2021."

Answered by AI

What are the common conditions that Rifaximin is used to address?

"Rifaximin is primarily used to treat clostridium difficile infection recurrence. It can also be useful in managing symptoms for patients with irritable bowel syndrome (IBS), bacterial infections, and diarrhea."

Answered by AI

How many individuals are enrolled in this experiment?

"That is accurate. The listing for this clinical trial on clinicaltrials.gov specifies that the trial is currently ongoing, with 20 patients being recruited from a single location. The listing was created on 9/15/2021 and updated as recently as 11/23/2021."

Answered by AI

Who might be most benefited by participating in this research?

"20 participants who meet the following criteria are needed for this study: must be between 18-89 years old, have an upper gastrointestinal motility disorder, and cannot have had a transjugular intrahepatic portosystemic shunt (TIPS) placed or prior overt hepatic encephalopathy. Furthermore, these patients must also test positive for CHE [two of the following should be abnormal as compared to healthy controls: number connection test A/B (NCT-A/B), Digit Symbol Test (DST), or Block Design Test (BDT)] at least 2 months prior to the start of the study"

Answered by AI