immune checkpoint inhibitor related colitis
Conditions
Interventions
Intervention:Fecal Microbiota Transplantation
Sponsors
The First Medical Center, Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Patients with malignancy who received immune checkpoint inhibitor therapy within six months 2) The main symptoms are diarrhea or bloody purulent stool that could not explain by other disease 3) Colonoscopy suggests diffuse or scattered erythema, exudation, ulceration, or loss of vascular shape 4) Voluntary to receive fecal microbiota transplantation treatment
Exclusion criteria
Exclusion criteria: 1) Diarrhea or bloody purulent stool that could explain by other disease 2) Have a history of neuropsychiatric disorders or alcohol abuse 3) Patients who received antibiotics within one week 4) Patients who have other severe disease like severe hepatic insufficiency, heart insufficiency or renal insufficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mayo Score;Endoscopic pathological results; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse reactions and grading;Colonitis severity grading;C-reactive protein;erythrocyte sedimentation rate(ESR);weight;Immune cell subpopulation; | — |
Countries
China
Contacts
Public ContactPan Fei
The First Medical Center, Chinese PLA General Hospital
Outcome results
None listed