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A prospective observational study of combination of Clostridium butyricum therapy and immune checkpoint inhibitors for thoracic malignancies

Not Applicable
Recruiting
Conditions
Thoracic malingancies
Registration Number
JPRN-UMIN000043045
Lead Sponsor
Kumamoto University Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
140
Inclusion Criteria

Not provided

Exclusion Criteria

None

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Changes in fecal microflora pre and post treatment with immune checkpoint inhibitors
Secondary Outcome Measures
NameTimeMethod
The following survival and safety analyses Progression free survival(PFS) 6 months PFS rate 1 year survival rate Overall survival Objective response rate Duration of response Safety (irAEs, diarrhea, etc.) Survival analysis of cases with antibiotic drugs Survival analysis of cases with proton pump inhibitor Analysis of the relationship with the results of food intake questionnaire
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