A Study of the Efficacy and Safety of Faecal Microbiota Transplant for the Treatment of Immune Checkpoint Inhibitor Colitis

Not Applicable

Recruiting

• Conditions: Immune Checkpoint Inhibitor Colitis; Inflammatory and Immune System - Other inflammatory or immune system disorders; Cancer - Any cancer; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12624000120572
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-09
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

18 years of age or older.
- Able to provide informed consent.
- Receipt of an immune checkpoint inhibitor agent (e.g. anti-CTLA-4, anti-PD-(L)1) as part of a treatment regimen for a solid cancer within 6 months of the onset of colitis symptoms. The ICI may be used as a single agent, or in combination with other ICIs, or with chemotherapy.
- Current diagnosis of immune-related diarrhoea and/or colitis characterized by grade 2 diarrhea as per CTCAE v5.0.
- Treatment including corticosteroid and biologic naive

Exclusion Criteria

- Patients who have received either corticosteroid or immunosuppressive treatment for the current episode of ICI colitis
- Life-threatening food allergies, e.g. nut allergy
- Patients unable to provide informed consent
- Patients with a known diagnosis of inflammatory bowel disease
- Patients with a previous total colectomy
- Patients with an –ostomy (i.e. ileostomy or colostomy)
- Diagnosis of a thromboembolic event (deep vein thrombosis, pulmonary embolism, embolic stroke, myocardial infarction, or peripheral arterial insufficiency) within 3 months of enrollment.
- Diagnosis of concomitant infectious colitis (e.g. C. difficile or other bacterial source), unless the patient has finished an appropriate length of treatment with antibiotics as indicated for each diagnosis at the time of enrollment.
- Active pregnancy or breastfeeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified