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Fecal Microbial Transplant

Fecal Microbial Transplant for Hepatic Encephalopathy

Phase 1 & 2
Waitlist Available
Led By Jasmohan S. Bajaj, MD MS
Research Sponsored by VA Office of Research and Development
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 6 months
Awards & highlights

Study Summary

This trial is testing a new way to treat confusion in patients with end stage liver disease or cirrhosis, by replacing their bowel bacteria with healthy stool from another person.

Who is the study for?
This trial is for veterans with end-stage liver disease or cirrhosis who experience confusion due to high ammonia levels. Participants must be on hepatic encephalopathy treatment, not pregnant, able to consent, and agree to use contraception. Exclusions include severe immune system issues, recent hospitalizations or surgeries, certain blood count levels, and specific infections.Check my eligibility
What is being tested?
The study tests fecal microbial transplant (FMT) via enema and capsules against a placebo in treating bowel bacteria changes that cause confusion in cirrhosis patients. The goal is to see if FMT can reduce hospital visits and improve daily functioning over six months.See study design
What are the potential side effects?
Potential side effects of FMT may include digestive discomfort, infection risk from transplanted material, allergic reactions or intolerance to capsule ingredients. Specific side effects will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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
Serious adverse events related to FMT
Secondary outcome measures
Adverse events related to FMT
Change in microbial diversity in saliva
Change in microbial diversity in stool
+4 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Group 1: Dual Oral and rectal FMTExperimental Treatment2 Interventions
Dual Oral and rectal FMT at visit 2 Oral FMT at day 30
Group II: Group 2: Oral FMT and rectal placeboActive Control1 Intervention
Oral FMT and rectal placebo at visit 2 Oral FMT at day 30
Group III: Group 3: Oral placebo and rectal FMTActive Control2 Interventions
Oral placebo and rectal FMT at visit 2 Oral placebo at day 30
Group IV: PlaceboPlacebo Group1 Intervention
Oral and rectal placebo at visit 2 Oral placebo at day 30
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fecal Microbial Transplant Enema
2019
Completed Phase 2
~60
Fecal Microbial transplant Capsules
2019
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,543 Total Patients Enrolled
3 Trials studying Liver Cirrhosis
282 Patients Enrolled for Liver Cirrhosis
Jasmohan S. Bajaj, MD MSPrincipal InvestigatorHunter Holmes McGuire VA Medical Center, Richmond, VA

Media Library

Fecal Microbial transplant Capsules (Fecal Microbial Transplant) Clinical Trial Eligibility Overview. Trial Name: NCT03796598 — Phase 1 & 2
Liver Cirrhosis Research Study Groups: Placebo, Group 1: Dual Oral and rectal FMT, Group 2: Oral FMT and rectal placebo, Group 3: Oral placebo and rectal FMT
Liver Cirrhosis Clinical Trial 2023: Fecal Microbial transplant Capsules Highlights & Side Effects. Trial Name: NCT03796598 — Phase 1 & 2
Fecal Microbial transplant Capsules (Fecal Microbial Transplant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03796598 — Phase 1 & 2

Frequently Asked Questions

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

Could I be accepted as a participant in this medical trial?

"This clinical trial is recruiting 60 adults between the ages of 21 and 75 that have been diagnosed with hepatic coma. In addition to this prerequisite, female participants must agree to use reliable contraceptive measures from 10 days prior to their involvement in the study until 30 days after its completion. Also, these patients must meet one or more of the following criteria: Liver Biopsy/Radiologic evidence for varices/cirrhosis/portal hypertension, Platelet count <100K or AST/ALT ratio>1, Endoscopic proof for portal gastropathy/varices, Fibroscan values suggestive of cirrhosis on treatment for"

Answered by AI

To what extent is the participant pool for this clinical trial expanding?

"Affirmative. The database of clinicaltrials.gov divulges that this analysis is currently searching for research subjects, with the first post having been made on July 29th 2019 and its most recent update being recorded on March 23rd 2022. 60 people are required to be enrolled at a single site."

Answered by AI

Are there any vacancies for enrolment in this experiment?

"Verified. According to clinicaltrials.gov, this medical trial is still enrolling participants; it was first advertised on July 29th 2019 and its details were last modified on March 23rd 2022. The study requires 60 individuals from a single hospital site."

Answered by AI

Does this trial include individuals above the age of majority?

"Per the outlined stipulations, only individuals aged 21 to 75 may join this trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
FMT in Cirrhosis and Hepatic Encephalopathy
2019. "FMT in Cirrhosis and Hepatic Encephalopathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03796598.
~11 spots leftby Apr 2025
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