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Establishment of a method for predicting therapeutic efficacy and adverse effects of drug therapy for hepatocellular carcinoma using tests related to the intestinal microbiota and elucidation of the mechanism

Not Applicable
Conditions
Chronic Hepatitis, Hepatocellular Carcinoma, Liver cirrhosis
Registration Number
JPRN-UMIN000052641
Lead Sponsor
agoya University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
100
Inclusion Criteria

Not provided

Exclusion Criteria

Patients with galactosemia Patients who have experienced allergies to foods containing sugar alcohols Patients with poorly controlled diabetes Patients who wish to be excluded from the study Patients who are pregnant, nursing, possibly pregnant or wish to become pregnant, or wishing to raise children Other patients whom the physician has judged to be inappropriate for safely conducting this trial

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
In patients with hepatocellular carcinoma undergoing chemotherapy, identifying differences in gut microbiota and intestinal permeability between the groups with favorable treatment outcomes (where the response during administration is evaluated as stable disease (SD) or better, according to m-RECIST and RECIST criteria) and the groups with unfavorable outcomes (where the response during administration is evaluated as progressive disease (PD)).
Secondary Outcome Measures
NameTimeMethod
Identification of gut microbiota and differences in intestinal permeability associated with adverse events during the treatment period.
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