Investigational Microbiota Restoration Therapeutic for Hepatic Encephalopathy

Phase 2

Waitlist Available

Led By Julia Garcia-Diaz, MD

Research Sponsored by Ochsner Health System

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 3 to 12 months

Summary

This trial is testing a new treatment that changes gut bacteria to help people with liver disease who have brain function problems. The goal is to see if this can reduce confusion and improve mental clarity. Researchers will also look at changes in blood markers to diagnose and treat these issues earlier.

Eligible Conditions

Liver Cirrhosis
Hepatic Encephalopathy
Encephalopathy

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in cognitive function at 1 month post-FMT as measured by change in response times on EncephalApp (Stroop test)

Secondary study objectives

Change in cognitive function at 3, 6 and 12 months post-FMT as measured by change in response times on EncephalApp (Stroop test)

Engraftment of FMT as assessed by change in type and abundance of gut microbiota following shotgun sequencing

Number of HE episodes

Other study objectives

Correlations of clinical variables with primary

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Low doseExperimental Treatment1 Intervention

Capsules of active drug will be supplied in 4-capsule blister packets to be taken twice per week for four weeks. Blood and stool samples and cognitive assessments will be collected before treatment and at 1, 3, 6, and 12 months after treatment.

Group II: High doseExperimental Treatment1 Intervention

Capsules of active drug will be supplied in 8-capsule blister packets to be taken twice per week for four weeks. Blood and stool samples and cognitive assessments will be collected before treatment and at 1, 3, 6, and 12 months after treatment.

Group III: pill quantity-matched PlaceboPlacebo Group1 Intervention

Capsules of inactive compound will be supplied in 8- or 4-capsule blister packets to be taken twice per week for four weeks. Blood and stool samples and cognitive assessments will be collected before treatment and at 1, 3, 6, and 12 months after treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

RBX7455

2016

Completed Phase 1

~30

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