The Role of Bacterial Overgrowth and Delayed Intestinal Transit in Hepatic Encephalopathy.

This study has been terminated.
(PI no longer at NYUMC)
Sponsor:
Collaborator:
Valeant Pharmaceuticals International, Inc.
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01846806
First received: May 1, 2013
Last updated: March 10, 2016
Last verified: March 2016
  Purpose

This is a prospective study designed to examine the role of bacterial overgrowth and delayed intestinal transit and the effect of Rifaximin with hepatic encephalopathy (HE). This study is divided into Phase A and Phase B. The purpose of Phase A is to test patients with cirrhosis to determine if they have bacterial overgrowth which may lead to slow intestinal transit and hepatic encephalopathy. The purpose of Phase B is to investigate whether the improvement found in patients with hepatic encephalopathy taking Rifaximin is also related to decreased bacterial overgrowth.

Subjects' mental capacity will be assessed at each visit via interview, brief mental status, questionnaires and psychometric evaluation. Any subject who appears to have lost capacity to continue participation, as evidenced by HE grade 2 or higher, a lack of attentiveness, concentration, or understanding of evaluation, will be discontinued from the study. Female subjects of childbearing potential will be asked to comply with the use of contraception during the Phase B study period as well as throughout the time they remain on study drug.


Condition Intervention
Hepatic Encephalopathy
Drug: Rifaximin

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Role of Bacterial Overgrowth and Delayed Intestinal Transit in Hepatic Encephalopathy

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Lactulose Hydrogen Breath Test [ Time Frame: Day 3 and Day 14 ] [ Designated as safety issue: No ]
    This test is designed to evaluate both intestinal transit and bacterial overgrowth. Subjects will be asked to breathe into a collection bag, drink 10g of lactulose that has been mixed with 8 oz of water, breathe again into the collection bag after waiting 20 minutes and then again every 10 minutes for a total of 2 hours.


Secondary Outcome Measures:
  • Hepatic Encephalopathy [ Time Frame: Phase A (Screening), Phase B (Day 1, Day 14, and Day 28) ] [ Designated as safety issue: No ]
    Subjects will be administered the Number Connection Test, WAIS-III Block Design and Digit Symbol Coding, DKEFS Trail Making and Color Word Interference, and California Verbal Learning Test-II

  • Quality of Life [ Time Frame: Phase A (Evaluation), Phase B (Day 1, Day 14, and Day 28) ] [ Designated as safety issue: No ]
    Subjects will be asked to complete the Beck Depression Inventory-II, Liver Disease Quality of Life Questionnaire, Fisk Fatigue Impact Scale, Epworth Sleepiness Scale, and Hamilton Depression Inventory

  • Laboratory Tests [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
    Results will be evaluated for the following lab tests: blood chemistry (including ammonia and other potential toxins) and hematology panels


Enrollment: 10
Study Start Date: September 2012
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rifaximin
Participants in Phase B will be administered 550 mg of Rifaximin two times a day for 14 days.
Drug: Rifaximin
Participants in Phase B will be administered 550 mg of Rifaximin two times a day for 14 days.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ambulatory patients with HCV cirrhosis will be screened for participation in the study
  • Ability to complete Number Connection Test
  • Creatinine <1.5mg/dL
  • Able to provide informed consent
  • Patients determined to possibly meet the West Haven criteria grade 0 or 1 for HE

Exclusion Criteria:

  • Active interferon therapy
  • History of alcohol abuse within six months
  • Active gastrointestinal bleeding
  • Use of agents that alter intestinal motility, e.g., methadone, cholestyramine, Tricyclic antidepressants, etc.
  • Use of Neomycin or other antibiotics within the past 2 weeks
  • Pregnancy
  • Unable to provide informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01846806

Locations
United States, New York
NYU Medical Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Valeant Pharmaceuticals International, Inc.
Investigators
Principal Investigator: Samuel Sigal, M.D. NYU Langone Medical Center
  More Information

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01846806     History of Changes
Other Study ID Numbers: 10-00570 
Study First Received: May 1, 2013
Last Updated: March 10, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by New York University School of Medicine:
Hepatic Encephalopathy

Additional relevant MeSH terms:
Brain Diseases
Hepatic Encephalopathy
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases
Rifaximin
Rifamycins
Anti-Infective Agents
Gastrointestinal Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on August 25, 2016