A prospective cohort study of combination of Clostridium butyricum therapy and immune therapy for thoracic malignancies

A prospective cohort study of combination of Clostridium butyricum therapy and immune therapy for thoracic malignancies - A prospective cohort study of combination of Clostridium butyricum therapy and immune therapy for thoracic malignancies

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000043045

Enrollment

400

Registered

2021-01-20

Start date

2021-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thoracic malingancies

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically or cytologically confirmed thoracic malignancies 2. The patient is scheduled to receive an immune therapy. 3. History of chemotherapy is not required. 4. Presence of measurable lesions is not required. 5. ECOG PS is not required. 6. Patients must be at least 20 years of age. 7. Expression of PD-L1 is not required. 8. Consent has been obtained in writing.

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
Changes in fecal microflora pre and post treatment with immune therapy	—

Secondary

Measure	Time frame
The following survival and safety analyses Progression free survival(PFS) 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	—

Countries

Japan

Contacts

Public ContactTokunaga Ryuki

Kumamoto University Hospital Department of Respiratory Medicine

nyamo317@hotmail.co.jp096-373-5012

Outcome results