Fecal Microbiota Transplantation With Immune Checkpoint Inhibitors in Lung Cancer

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• Patient (Recipient) Inclusion Criteria:
• A histologically confirmed diagnosis of malignancy.
• Patients over the age of 18.
• Patients planning to be treated with chemotherapy, immune checkpoint inhibitors and/or targeted therapy.
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
• Able to provide written informed consent.
  • Patient (Recipient) Exclusion Criteria:
• Severe or life-threatening food allergy (e.g. nuts, seafood)
• Allergy or other contraindication to omeprazole, investigational medicinal product.
• Treatment with pre- or probiotics in the four weeks prior to randomization.
• Severe immunodeficiency:
  • Systemic chemotherapy \<30 days from baseline
  • Known neutropenia with absolute neutrophils \<1.0x109 cells/µL
  • Prolonged treatment with corticosteroids (equivalent to prednisone \>60mg daily for \>30 days) within 8 weeks of randomization
• Swallowing disorder, oral-motor discoordination, inability to swallow capsules
• Pregnant or breastfeeding or expecting to conceive or father children within the trial's projected duration, starting from the pre-screening or screening visit through to 120 days after the last dose of trial treatment.
  • Donor Inclusion Criteria:
• A histologically confirmed diagnosis of malignancy.
• Over the age of 18.
• Treated with immune checkpoint inhibitors and with a full response.
• Currently attending medical follow-ups
  • Donor Exclusion Criteria:
• Has not consumed any antimicrobials within the past 3 months
• No prior exposure to HIV or viral hepatitis or suffering from tuberculosis/latent tuberculosis
• No risk factors for blood-borne viruses, including high-risk sexual behavior, use of illicit drugs, any tattoo/body piercing/needlestick injury/blood transfusion/acupuncture, all within the past 6 months
• No signs or symptoms consistent with Coronavirus disease 19 (COVID-19) or a nose/throat and/or stool sample with detectable Coronavirus disease 2 (CoV-2)
• Has not received a live attenuated vaccine within the past 6 months
• No underlying gastrointestinal conditions/symptoms (e.g., history of IBD, irritable bowel syndrome (IBS), chronic diarrhea, chronic constipation, coeliac disease, bowel resection or bariatric surgery)
• No acute diarrhea/gastrointestinal symptoms within the 2 weeks prior to donating
• No family history of any significant gastrointestinal conditions (e.g., family history of inflammatory bowel disease (IBD) or colorectal cancer)
• No history of atopy (e.g., asthma, eosinophilic disorders)
• Does not suffer from any systemic autoimmune conditions
• Does not start any new treatment regimens within 2 weeks of fecal collection
• No neurological or psychiatric conditions or known risk for prion disease
• No history of chronic pain syndromes, including chronic fatigue syndrome and fibromyalgia
• No history of receiving growth hormone, insulin from cows or clotting factor concentrates
• Has not received an experimental drug or vaccine within the past 6 months
• No history of travel to tropical countries within the past 6 months