Microbiome product gets the green light from the TGA

Australian Red Cross Lifeblood’s life-changing donor stool product has received Therapeutic Goods Administration (TGA) approval for use in patients with a potentially life-threatening bowel infection.

Lifeblood can now supply hospitals across Australia with Faecal Microbiota Transplants, known as FMT, to treat patients with Clostridioides difficile infections (CDI).  

CDI is a serious bacterial infection within the gut and affects around 2,500 Australians a year. It occurs in some patients who’ve had treatment with antibiotics and causes debilitating symptoms including pervasive diarrhoea, stomach pain, fever and in rare cases can even be fatal. 

Lifeblood Executive Director Stuart Chesneau said Lifeblood was thrilled to now be able to supply FMT to hospitals for use in treating CDI outside of clinical trials.

“When we launched our microbiome program five years ago, our aim was to increase patient access to FMT and help thousands of Australians struggling to recover from this nasty infection,” Mr Chesneau said. 

“We’re very excited this goal has become a reality, with the help of many generous, unpaid microbiota donors.”

FMT is made by collecting stool from a healthy donor at Lifeblood’s Microbiota Donor Centre in Perth, located within the Rotary WA Health Innovation Centre. It is then tested by our testing partners PathWest and processed before being supplied to hospitals to transplant to patients through enema or colonoscopy. Just like blood donors, microbiota donors are rigorously screened.

Mr Chesneau said Lifeblood was committed to exploring how FMT might be beneficial for patients with other medical conditions.

“At Lifeblood we believe in using our knowledge and skills to help Australian patients from all walks of life.

“Currently we’re also supporting clinical trials and research programs focused on patients with Graft v Host Disease, Immune Checkpoint Inhibitor Colitis and restoration of gut microbiota in patients with Persistent Critical Illness.

“We’re also collaborating with Curtin University to design and co-develop a more patient-friendly, orally administered liquid frozen FMT capsule for use in clinical trials.” 

Lifeblood is funded by Australian governments to provide blood, blood products and services to the Australian Community. For Microbiome, Lifeblood has been grateful to receive generous contributions from the Western Australian Government (through the Market-led Proposals funding pathway), Rotary WA, HBF, the McCusker Charitable Foundation and the Honda Foundation.

For more information about Lifeblood’s Microbiome Program, visit lifeblood.com.au/microbiome.