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Microbiota Restoration Therapy

RBX7455 for Liver Cirrhosis

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

Awards & highlights

Study Summary

This trial is testing a new treatment for people with cirrhosis who experience hepatic encephalopathy, a condition that causes cognitive alterations. The new treatment is microbiota restoration therapy, which involves restoring the microbiome.

Eligible Conditions

Liver Cirrhosis
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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 outcome measures

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ochsner Health SystemLead Sponsor

93 Previous Clinical Trials

184,656 Total Patients Enrolled

1 Trials studying Liver Cirrhosis

Rebiotix Inc.Industry Sponsor

8 Previous Clinical Trials

1,627 Total Patients Enrolled

Julia Garcia-Diaz, MDPrincipal InvestigatorOchsner Health System

1 Previous Clinical Trials

50 Total Patients Enrolled

Media Library

RBX7455 (Microbiota Restoration Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04155099 — Phase 2

Liver Cirrhosis Research Study Groups: High dose, Low dose, pill quantity-matched Placebo

Liver Cirrhosis Clinical Trial 2023: RBX7455 Highlights & Side Effects. Trial Name: NCT04155099 — Phase 2

RBX7455 (Microbiota Restoration Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04155099 — Phase 2

Frequently Asked Questions

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

Is there an age cutoff for admission to this medical experiment?

"This clinical trial is only available to participants aged between 18 and 75. Nevertheless, there are other trials for younger patients (75) and elderly individuals (283)."

Answered by AI

Has RBX7455 acquired regulatory approval from the FDA?

"Based on the available data, our team at Power regards RBX7455 as relatively safe and gave it a rating of 2. This is because Phase 2 trials typically provide evidence to support safety but do not have any efficacy data yet."

Answered by AI

Is there an opportunity for me to volunteer in this clinical investigation?

"This research seeks to enrol 75 individuals aged between 18 and 70 who have hepatic encephalopathy. Applicants must be self-sufficient in the use of electronic equipment after training, identify as male or female and have previously experienced a HE episode."

Answered by AI

Is this research endeavor open to recruiting participants?

"Affirmative, according to the data hosted on clinicaltrials.gov, this medical study is recruiting participants. It was initially posted on March 1st 2021 and last revised on September 21st of the same year - 75 patients are needed from one location."

Answered by AI

How many individuals can partake in this experiment?

"Indeed, according to clinicaltrials.gov this trial is still recruiting candidates. Initially posted on March 1st 2021 and recently updated on September 21st 2021, the medical study seeks 75 participants at one specific site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Investigational Microbiota Restoration Therapeutic for Hepatic Encephalopathy

Julia Garcia-Diaz 2021. "Investigational Microbiota Restoration Therapeutic for Hepatic Encephalopathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04155099.