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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04244877
Other study ID # IRB17-00550
Secondary ID
Status Withdrawn
Phase Phase 3
First received
Last updated
Start date September 15, 2021
Est. completion date December 2023

Study information

Verified date June 2023
Source MetroHealth Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Small Intestinal Bacterial Overgrowth (SIBO) is a common and increasingly recognized disorder in cirrhosis (30% to 73%). One of the most important predisposing factors of SIBO is small bowel dysmotility. Multiple studies have shown that the presence of SIBO is strongly linked to the pathogenesis of Minimal Hepatic Encephalopathy (MHE) also known as Covert Hepatic Encephalopathy (CHE). Consequently, altering and modulating the intestinal microbiota with ammonia-lowering agents and Rifaximin has been the target treatment strategy in CHE. The aim of this study is to determine the therapeutic effect of Rifaximin on patients with CHE and underlying SIBO while assessing the influence of Rifaximin on small bowel motility. In this prospective interventional study, 40 patients with liver cirrhosis will be screened for Covert Hepatic Encephalopathy (CHE) using neuro-psychometric tests. Patients diagnosed with CHE will undergo breath test (BT) for SIBO screening. Afterwards, wireless motility capsule (The SmartPill) will be performed in all patients with a positive BT. Thereafter, the cirrhotic patients diagnosed with CHE and SIBO will receive Rifaximin 550 mg PO twice daily for eight weeks. At the end of treatment, neuro-psychometric tests will be repeated to evaluate the therapeutic effect on CHE. In addition, BT and SmartPill will be repeated at the completion of the Rifaximin treatment period to assess the effect on small bowel motility. All collected clinical parameters at the end of the study will be compared to baseline values.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Rifaximin
Drug: Rifaximin tablet

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
MetroHealth Medical Center

References & Publications (19)

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Outcome

Type Measure Description Time frame Safety issue
Primary Comparing the effects of Rifaximin on patients with covert hepatic encephalopathy (CHE) and SIBO using neuropsychometric test (NST) and glucose hydrogen breath test (BT) after 8 weeks of Rifaximin. The percent of subjects with improvement on Portosystemic Encephalopathy Syndrome test (PSE) after taking Rifaximin for 8 weeks. The percent of subjects who test negative on glucose breath test (BT) after treatment with Rifaximin. 8 weeks
Secondary Improvement in small bowel motility in subjects taking Rifaximin The percent of patients with improvement in small bowel motility as measured by the SmartPill after taking Rifaximin for 8 weeks 8 weeks
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