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

NCT01846806 | Terminated DMC

• 1 other identifier: 10-00570
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatic Encephalopathy

Keywords

Hepatic Encephalopathy

Outcome Measures

Primary Outcomes (1)

• Lactulose Hydrogen Breath Test

  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.

  Day 3 and Day 14

Secondary Outcomes (3)

• Hepatic Encephalopathy

  Phase A (Screening), Phase B (Day 1, Day 14, and Day 28)

• Quality of Life

  Phase A (Evaluation), Phase B (Day 1, Day 14, and Day 28)

• Laboratory Tests

  3 days

Study Arms (1)

Rifaximin

EXPERIMENTAL

Participants in Phase B will be administered 550 mg of Rifaximin two times a day for 14 days.

Other: Rifaximin

Interventions

Rifaximin OTHER

Participants in Phase B will be administered 550 mg of Rifaximin two times a day for 14 days.

Rifaximin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• Bausch Health Americas, Inc.: collaborator

Study Sites (1)

NYU Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Hepatic Encephalopathy

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Samuel Sigal, M.D.

  NYU Langone Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2013
• First Posted: May 3, 2013
• Study Start: September 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: August 4, 2017

Record last verified: 2017-08

Locations

US (1)