Discussion
enema, dysbiosis, gastro-intestinal disturbance
EVENTS
There is a lack of safety and dosing data regarding autologous faecal microbiota transplantation. The primary aim of this study was therefore to evaluate the safety and tolerability of acid-resistant capsules containing autologous microbiota compared to placebo in healthy subjects. Auto-FMT given as two capsules twice daily for 5 days were well tolerated in line with previous data where enema or nasogastric tubes were used for single auto-FMT deliveries [The similarity of reported gastro-intestinal health, general wellbeing, and time to normalized stool pattern in the placebo and auto-FMT groups suggests that auto-FMT did not result in faster resolution of gastro-intestinal disturbance induced by clindamycin. There are several possible explanations for this. The study population was young and healthy and therefore able to rapidly and spontaneously resolve clindamycin induced gastro-intestinal disturbance. This is supported by a study where auto-FMT did not shorten time to normalized microbiota, compared with placebo, in similarly healthy study subjects in whom dysbiosis was induced by antibiotics [The apparent safety, potential beneficial metabolic effects, ability to restore antibiotic induced dysbiosis, and low risk of pathogen spread from donors suggests that auto-FMT may become an effective and safe treatment [Limitations of the study include samples size, non-observed treatment, and lack of data on stool habits prior to clindamycin treatment. The design with a questionnaire to evaluate side effects might not show us all possible events. Another limitation is that we have not been able to report microbiome analyses data that would have been of importance for our conclusions. Moreover, generalizability is affected by inviting young and healthy study subjects that contrasts with the typical FMT recipient. Nevertheless, these data are in line with previous reports [To conclude, the present study shows that intake of two acid-resistant capsules containing autologous microbiota twice daily for 5 days was safe and well tolerated supporting future dosing and efficacy studies.