None listed
Conditions
Brief summary
The immune checkpoint inhibitors (ICI) are a form of cancer treatment that have resulted in significant improvement in the outcomes of the management of a number of malignancies. They work by activating the immune system and thereby promoting the destruction of cancer cells. The use of ICIs is limited by a group of side-effects known as immune related adverse events (irAEs). One of the more common irAEs is the development of inflammation of the large intestine known as ICI colitis. The treatment of ICI colitis is mostly aimed at suppressing the immune system and ‘switching off’ the overactive immune cells that are causing the inflammation. The use of treatments that suppress the Immune system may themselves result in significant side-effects by increasing the risk of infection. Immune suppression may have a detrimental impact on the outcome of the cancer being treated, by reducing the ability of the patient’s immune system to control the cancer. Who is it for? You may be eligible for this study if you are an adult who is receiving treatment for a solid cancer, who has experienced onset of colitis symptoms within 6 months of treatment commencement. Study details Participants in this study will be able to choose if they wish to receive the intervention or are considered part of the 'control' group. Participants who choose to receive the intervention will undergo a colonoscopy where they will receive a faecal transplant. If a participant chooses not to receive the intervention, they will continue with standard treatment as determined by their doctor. All participants will then be followed up for 8 weeks and asked to complete questionnaires and provide additional blood and stool samples. It is hoped that this study will help assess the efficacy and safety of Faecal Microbiota Transplant as first-line therapy in the treatment of ICI colitis.
Interventions
This will be an open-label study, all potential participants will be offered the intervention.
Faecal Microbiota Transplant (FMT) - provided by The Australian Red Cross Lifeblood
A suspension of faecal microbiota derived from 50g of human stool from an individual screened donor in a mixture of Glycerolyte-57 and normal saline, to achieve an equivalent concentration of 10% glycerol as a cryoprotectant. The suspension is filtered to remove particles >1mm.
Faecal Microbiota for Transplant (Faeca
This will be an open-label study, all potential participants will be offered the intervention. Faecal Microbiota Transplant (FMT) - provided by The Australian Red Cross Lifeblood A suspension of faecal microbiota derived from 50g of human stool from an individual screened donor in a mixture of Glycerolyte-57 and normal saline, to achieve an equivalent concentration of 10% glycerol as a cryoprotectant. The suspension is filtered to remove particles >1mm. Faecal Microbiota for Transplant (Faecal microbiota cryopreserved in glycerol) – is designed for administration to the patient’s caecum via colonoscopy as a single 150g dose. The procedure including both colonoscopy and faecal transplant will be performed by a consultant gastroenterologist and will take approximately 30 minutes. This will be administered once only on Day 0 of the study.
Sponsors
Monash University
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed