Orally Administered Faecal Microbial Transplantation in the Management of Immune Checkpoint Inhibitor Associated Colitis
Not Applicable
Recruiting
- Conditions
- Immune Checkpoint inhibitor ColitisCancer - Other cancer types
- Registration Number
- ACTRN12622000914763
- Lead Sponsor
- St Vincent's Hospital Sydney
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 46
Inclusion Criteria
•Grade 2 or more diarrhoea (greater than 4 bowel actions more than baseline)
•Last dose of checkpoint inhibitor within 4 months of symptom onset
Either
•No response to oral glucocorticoids
OR
•Steroid intolerant
OR
•Recurrence of symptoms during or following corticosteroid wean
Or
•Recurrent episode of immune checkpoint inhibitor colitis.
Exclusion Criteria
-Infective colitis
-Inflammatory bowel disease
-Previous colectomy
-Significant medical comorbidity
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method