What side effects are associated with this type of intervention?

Rifaximin, a common treatment for hepatic encephalopathy, is generally well-tolerated but can cause side effects such as nausea, fatigue, dizziness, peripheral edema, and ascites. Other treatments that alter gut microbiota and reduce ammonia production, like lactulose, may cause gastrointestinal symptoms including diarrhea, bloating, and abdominal pain. These side effects are typically mild and manageable with dose adjustments.

What prior FDA approvals exist?

Rifaximin, an antibiotic that alters gut microbiota and reduces ammonia production, has been FDA-approved for the treatment of hepatic encephalopathy. It works by decreasing the production of ammonia by gut bacteria, thereby reducing the risk of encephalopathy in patients with liver cirrhosis. Another related drug is lactulose, a non-absorbable disaccharide that also helps reduce blood ammonia levels by promoting its excretion through the gastrointestinal tract. Both treatments are aimed at managing and preventing episodes of hepatic encephalopathy by targeting gut-derived ammonia.

What other types of research exist?

The provided context does not mention specific novel alternatives to Rifaximin SSD-40mg IR for hepatic encephalopathy. However, patients should discuss with their healthcare provider about emerging treatments and ongoing clinical trials that may offer new options in 2024.

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Antibiotic

Rifaximin SSD for Encephalopathy (RED-C-3131 Trial)

Phase 3

Waitlist Available

Research Sponsored by Bausch Health Americas, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Are you between the ages of 18 and 85 years old?

Have you been diagnosed with liver cirrhosis?

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Summary

This trial tests an oral antibiotic called rifaximin to see if it can delay brain problems in people with liver disease and fluid buildup in the abdomen. Rifaximin is commonly used to treat hepatic encephalopathy and has shown efficacy in reducing recurrence and improving symptoms in patients with liver disease.

Who is the study for?

This trial is for adults aged 18-85 with liver cirrhosis who haven't had an overt hepatic encephalopathy episode yet. Participants should not have a recent history of substance abuse, excessive alcohol consumption, or be in another clinical study. They must not have used Rifaximin or lactulose for hepatic encephalopathy before.

What is being tested?

The study is testing if a new form of the drug Rifaximin (40mg SSD) can prevent worsening brain function problems in people with liver cirrhosis compared to a placebo. It's randomized and double-blind, meaning neither the researchers nor participants know who gets the real drug.

What are the potential side effects?

While specific side effects are not listed here, Rifaximin may commonly cause gastrointestinal symptoms like nausea or create an environment where resistant bacteria can grow.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Rifaximin SSD-40mg IRExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rifaximin SSD

2015

Completed Phase 2

~20

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for encephalopathy, such as Rifaximin SSD-40mg IR, work by altering the gut microbiota and reducing the production of ammonia. Rifaximin, a non-absorbable antibiotic, decreases the population of ammonia-producing bacteria in the gut, thereby lowering blood ammonia levels, which is crucial because elevated ammonia is a key factor in the development of hepatic encephalopathy. By reducing ammonia production, these treatments help to prevent the neurotoxic effects of ammonia on the brain, thereby improving cognitive function and quality of life for encephalopathy patients.