Food and Drug Administration set to standardise faecal transfer procedure
Hyderabad: Drug-resistant germs passed from the faeces during a faecal transplant has led to two deaths in clinical trials prompting the Food and Drug Administration to halt the trials and ask the procedure to be stopped till a proper standardised mechanism is in place.
Faecal transplant is carried out in patients who are suffering from chronic diarrhoea and there is an increasing resistance found to antibiotics. There are 10,000 procedures which have been carried out globally on a trial basis. The gaps are being found in standardising a procedure for testing the donor stools. The clinical trial which had led to this alert was because after the death of two patients, the others reported sick to the hospital and they were found to have multiple organisms in their blood tests. The FDA has warned researchers and therapeutic practitioners that the donated stools had to be screened for multi-drug resistant microbes and not used if present.
Dr B. Ravi Shankar, organising secretary of Telangana Gastroenterology Association and senior gastroenterologist at Sunshine Hospitals, explained, “The treatment is so far approved for clostridium colitis and ulcerative colitis which are chronic forms of diarrhoea. The incidence of antibiotic resistance in clostridium colitis is not very high in India when compared to the West. The treatment is to be used very selectively. It cannot be used for all types of diarrohea. There are still clinical trials being carried out to vet the procedures.”
While the results of the treatment in the patients with chronic forms of diarrhoea have yielded scientifically acceptable results, the researchers state that further research would help to understand better.
After two deaths and FDA taking a strong stand on the procedures, doctors state that they want to tread with caution.
Dr B. Shravan, senior gastroenterologist, said, “We do not know whether the deaths were due to the faecal transplant. It needs to be verified. The treatment is used sparingly worldwide due to the reason that before developing the procedure it will be blamed.”
The questions raised about samples of faeces are valid and experts state that they have to create markers to identify the dangerous germs.
Developing of a standard procedure to test the feces and also ensure that it is healthy for transfer has to undergo pathological tests.
