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Fecal Transplant in Recurrent Hepatic Encephalopathy

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ClinicalTrials.gov Identifier: NCT02636647
Recruitment Status : Completed
First Posted : December 22, 2015
Last Update Posted : November 28, 2016
Sponsor:
Collaborator:
OpenBiome
Information provided by (Responsible Party):
Jasmohan Bajaj, Hunter Holmes Mcguire Veteran Affairs Medical Center

Brief Summary:

Randomized, open-label safety, tolerability study with exploratory endpoints and pathophysiological evaluation of the FMT

Two groups of outpatients with cirrhosis will be randomized using random sequence generator into no-treatment and FMT groups.


Condition or disease Intervention/treatment Phase
Hepatic Encephalopathy Cirrhosis Biological: Fecal transplant Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Safety and Tolerability of Fecal MicrobiotaTransplantation in Cirrhosis and Hepatic Encephalopathy
Study Start Date : October 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016


Arm Intervention/treatment
Active Comparator: FMT
Fecal transplant via enema once
Biological: Fecal transplant
No Intervention: No treatment
No transplant performed



Primary Outcome Measures :
  1. Safety and tolerability [ Time Frame: 5 months ]
    Defined by the rate of development of FMT-related SAE and withdrawal from the study in cirrhotic subjects


Secondary Outcome Measures :
  1. Microbiota composition and function [ Time Frame: 15 days ]
    Deep sequencing of the microbiota and urinary metabolomics at baseline and post-FMT

  2. Cognitive functioning [ Time Frame: 15 days ]
    Computerized and paper-pencil test battery



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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cirrhosis diagnosed by either of the following in a patient with chronic liver disease

    • Liver Biopsy
    • Radiologic evidence of varices, cirrhosis or portal hypertension
    • Laboratory evidence of platelet count <100,000 or AST/ALT ratio>1
    • Endoscopic evidence of varices or portal gastropathy
  • At least two episodes of hepatic encephalopathy, one within the last year but not within the last month (patient can be on lactulose and rifaximin)
  • Age between 21 and 75
  • Able to give written, informed consent (demonstrated by mini-mental status exam>25 at the time of consenting)

Exclusion Criteria:

  • MELD score >17
  • WBC count <1000 cells/mm3
  • Platelet count<50,000/mm3
  • On the liver transplant list
  • TIPS in place
  • No HE episode within a month prior to the study
  • Patients allergic to ciprofloxacin, penicillins or metronidazole
  • Currently on absorbable antibiotics
  • Infection at the time of the FMT (diagnosed by blood culture positivity, urinalysis, paracentesis as needed)
  • Hospitalization for any non-elective cause within the last 3 months
  • Patients who are aged >75 years
  • Patients who are pregnant or nursing (will be checked using a urine pregnancy test)
  • Patients who are incarcerated
  • Patients who are incapable of giving their own informed consent
  • Patients who are immuno-compromised due to the following reasons:

    • HIV infection (any CD4 count)
    • Inherited/primary immune disorders
    • Current or recent (<3 mos) treatment with anti-neoplastic agent
    • Current or recent (<3 mos) treatment with any immunosuppressant medications [including but not limited to monoclonal antibodies to B and T cells, anti-TNF agents, glucocorticoids, antimetabolites (azathioprine, 6-mercaptopurine), calcineurin inhibitors (tacrolimus, cyclosporine), mycophenolate mofetil]. Subjects who are otherwise immunocompetent and have discontinued any immunosuppressant medications 3 or more months prior to enrollment may be eligible to enroll.
  • Patients with a history of severe (anaphylactic) food allergy
  • Patients who have previously undergone FMT
  • Patients on renal replacement therapy
  • Patients who are unwilling or unable to hold the enemas
  • Patients with untreated, in-situ colorectal cancer
  • Patients with a history of chronic intrinsic GI diseases such as inflammatory bowel disease (ulcerative colitis, Crohn's disease or microscopic colitis) , eosinophilic gastroenteritis, celiac disease or irritable bowel syndrome
  • Major gastro-intestinal or intra-abdominal surgery in the last three months
  • Unable to comply with protocol requirements
  • Patients who are American Society of Anesthesiologists (ASA) Physical Status classification IV and V
  • Patients with acute illness or fever on the day of planned FMT will be excluded with the option of including that subject at a future date
  • Any conditions for which, in opinion of MD, the treatment may pose a health risk
  • C. difficile in the stool at baseline (qPCR)
  • Grade 2-4 or complicated hemorrhoids

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02636647


Locations
United States, Virginia
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States, 23249
Sponsors and Collaborators
Jasmohan Bajaj
OpenBiome

Responsible Party: Jasmohan Bajaj, MD, Hunter Holmes Mcguire Veteran Affairs Medical Center
ClinicalTrials.gov Identifier: NCT02636647     History of Changes
Other Study ID Numbers: BAJAJ0021
First Posted: December 22, 2015    Key Record Dates
Last Update Posted: November 28, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jasmohan Bajaj, Hunter Holmes Mcguire Veteran Affairs Medical Center:
hepatic encephalopathy
fecal transplant
cirrhosis

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Brain Diseases
Hepatic Encephalopathy
Pathologic Processes
Liver Diseases
Digestive System Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Brain Diseases, Metabolic
Metabolic Diseases