Fecal microbiota transplantation for immune checkpoint inhibitors(FMT for ICI)

JRCT ID: jRCTs041200003

Registered date:17/04/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Malignant tumors for which immune check point inhibitors are indications
• Date of first enrollment: 17/04/2020
• Target sample size: 50
• Study type: Interventional
• Intervention(s): fecal microbiota transplatation

Outcome(s)

• Primary Outcome: Difference in fecal microbiota between responsive and unresponsive groups by immune check point inhibitors

Secondary Outcome

Response rate and disease control rate of immune check point hinhibitors after fecal microbiota transplantation
PD-L1 expression, tumor-infiltrating T lympohocytes, and tumor mutational burden of tumors
Surface markers of peripheral blood lymphocytes before and after fecal microbiota transplantation

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients with the agreement in a document

Exclude criteria

1.Difficulty in FMT
2.Allergy to drugs used
3.Judged as unsuitable by researchers

Related Information

• Primary Sponsor: Ohmiya Naoki
• Source(s) of Monetary Support: Contributions for the specific public interest