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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: The Role of Bacterial Overgrowth and Delayed Intestinal Transit in Hepatic Encephalopathy

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.


Detailed 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. The target population is patients with chronic liver cirrhosis with or without symptoms of HE. Many patients may present with advanced cirrhosis and may be on the liver transplant list.

During Phase A, 20 patients will be asked to sign the informed consent form and will be assigned a subject number. They will be asked to provide demographic information, medical history, history of hospitalizations for HE, and HE medication use. They will undergo a complete physical examination, urine pregnancy test (women of childbearing potential), 12-lead EKG, grading of ascites, modified Child Pugh Score, MELD Score. They will also complete the following neuropsychological questionnaires: NCT, D-KEFS Trail Making Test, California Verbal Learning Test, WAIS-III Digit Symbol-Coding and Block Design, D-KEFS Stroop Color-Word Test, Evaluation of Constructional Apraxia, , and asterixis. During the evaluation visit (a minimum of 3 days after the Screening Visit) the following procedures will be performed: lab tests (chemistry and hematology panels). They will also complete the following questionnaires: Liver Disease Quality of Life Questionnaire, Fisk Fatigue Impact Score, Flatulence Survey, Epworth Sleepiness Scale. Finally, they will undergo a Lactulose Hydrogen Breath Test: This test is designed to evaluate both intestinal
Sponsor: New York University School of Medicine

Current Primary Outcome: Lactulose Hydrogen Breath Test [ Time Frame: Day 3 and Day 14 ]

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.


Original Primary Outcome:

  • Laboratory results [ Time Frame: 3 days ]
    Results will be evaluated for the following lab tests: blood chemistry (including ammonia and other potential toxins) and hematology panels
  • Lactulose Hydrogen Breath Test [ Time Frame: Day 3 and Day 14 ]
    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.
  • Quality of Life [ Time Frame: Day 3, Day 14, and Day 28 ]
    Participants will be asked to rate levels of depression, fatigue, and sleepiness, as well as decreases or increases in their quality of life.


Current Secondary Outcome:

  • Hepatic Encephalopathy [ Time Frame: Phase A (Screening), Phase B (Day 1, Day 14, and Day 28) ]
    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) ]
    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 ]
    Results will be evaluated for the following lab tests: blood chemistry (including ammonia and other potential toxins) and hematology panels


Original Secondary Outcome:

Information By: New York University School of Medicine

Dates:
Date Received: May 1, 2013
Date Started: September 2012
Date Completion:
Last Updated: March 10, 2016
Last Verified: March 2016