None listed
Conditions
Brief summary
This trial aims to test whether a Prebiotic Fibre Supplement (PFS) is tolerable and feasible in a CAR T treatment context. Who is it for? You may be eligible for this study if you are aged 18 or older and planned to receive CAR T therapy as part of standard of care. You would need to be able to take a twice daily PFS for up to 90 days. Study details Participants who choose to enrol in this study will receive standard of care CAR T and be randomly assigned to either standard supportive care or receive an oral prebiotic fibre supplement in addition to supportive care. Participants will be followed up for up to 6 months to assess for feasibility and safety, and documented for clinical response, adverse events, and gastrointestinal symptoms to CAR T therapy. It is hoped the outcomes from this study will provide insights into the relationship between diet, the microbiome and response to CAR T therapy. Ultimately, the goal is identify strategies to positively influence the gastrointestinal microbiome to improve outcomes for patients having CAR T therapy.
Interventions
Intervention arm patients receive an oral prebiotic fibre supplement in addition to standard of care CAR T and supportive care. The supplement will be taken twice per day from the day after collection of cells to manufacture CAR T until 30 days after CAR T administration (approximately 8-12 weeks supplementation period depending on CAR T manufacture time).
The prebiotic is a powdered fibre supplement mix of inulin (4g), resistant starch (8g), and psyllium (3.5g) combined into a single serve sa
Intervention arm patients receive an oral prebiotic fibre supplement in addition to standard of care CAR T and supportive care. The supplement will be taken twice per day from the day after collection of cells to manufacture CAR T until 30 days after CAR T administration (approximately 8-12 weeks supplementation period depending on CAR T manufacture time). The prebiotic is a powdered fibre supplement mix of inulin (4g), resistant starch (8g), and psyllium (3.5g) combined into a single serve sachet. Two sachets per day will provide a combined dose of 8g inulin, 16g resistant starch and 7g psyllium (providing 31g of supplement and a total of 22g fibre including 7g from inulin, 5g from psyllium and 10g from resistant starch). Adherence will be assessed by patient reporting as well as supplement sachet return.
Sponsors
Metro North Hospital and Health Service
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age greater than or equal to 18 years old Planned recipient of CAR T cell therapy as part of standard of care indication (DLBCL, MCL, B-ALL and Myeloma) Ability to provide voluntary informed consent. Willing and able to commence daily oral intake of PFS for potentially up to 90 days.
Exclusion criteria
Inflammatory bowel disease Formal diagnosis of irritable bowel syndrome Gastrointestinal resection, ileostomy or colostomy Any bariatric surgery including gastric bypass surgery, sleeve gastrectomy and gastric band Any other contraindication to a high fibre diet (e.g. active diverticulitis or bowel obstruction) Allergy/intolerance to any ingredient in the PFS Current and planned ongoing consumption of other probiotic or prebiotic supplements. Hepatitis B, hepatitis C or HIV infection unless viral load negative On carbamazepine Enrolled in CAR T cell clinical trial
Outcome results
None listed