A patient has died after using an experimental treatment being trialled on people with autism. The US patient, who has not yet been identified, was given a faecal transplant.
A second patient developed the same “invasive infection” following a transplant from the same donor, the US Food and Drug Administration (FDA) has confirmed.
Faecal transplant researcher James Adams: he insists his investigations will carry on
Both patients had weakened immune systems before the transplants and developed antibiotic-resistant infections.
No test on the donor
The donor was tested and found positive for the same infection. But medics did not carry out a test on the donor before the treatment took place.
The FDA has issued new guidance. It says medics should test donors for multi-drug-resistant organisms (MDROs).
Professor James Adams is a leading US researcher trialling faecal transplants for autism.
Adams, of Arizona State University, insisted the death would not affect his research.
In an email, Adams wrote: “We already meet (and exceed) those requirements, so this will not affect our research.
“Also, we check medical history and exclude people with compromised immune systems.”
Faecal transplant trials underway
In an email to Autism Eye, Adams confirmed he had started faecal transplant trials on 18 people. He added that he hoped to enrol another 66 for his latest study.
One of Adams’ earlier trials saw nearly half the participants lose their autism diagnosis.
He has insisted that most of the effect was “real” in the promising study.
Under the procedure, medics carry out faecal microbiota transplant (FMT) from a donor into a patient’s intestines.
Used for treating superbug
Doctors have used faecal transplants for treating superbug clostridium difficile (C. diff), which can lead to fatal diarrhoea.
The FDA encourages health care teams using faecal transplants to report suspected reactions.
Such reactions can be reported to the FDA here: http://www.fda.gov/medwatch.
Related:
- Could faecal transplants help adults?
- Study finds faecal transplants effective
- Bowel disease far more common in autism
- Study seeks proof of gut link to autism
- Stress ‘likely cause of gut issues’
- Evidence grows for autism link to gut
Published: 25 June 2019
