Fecal Microbiota Transplantation
With increasing recognition of the role of disturbed microbiota in development of various diseases, influencing and restoring the microbiota may provide proof of the concept that the microbiota is a causative factor in the pathogenesis. To date, FMT is an established treatment modality for recurrent CDIs. Persisting normalization of the disturbed bowel microbiota associated with CDI seems responsible for the therapeutic effect of FMT. New research has to focus on the optimal composition of microbiota given to patients with recurrent CDI. This will lead to better probiotic mixtures, which ultimately eliminate the need for donor screening and donor feces infusion in the future.
In early 2013, the US Food and Drug Administration (FDA) required an investigational new drug (IND) application for each FMT. This greatly restricted the implementation of routine FMTs. This policy has since been changed, and the FDA now exercises discretion if they are provided with an extended informed consent. In Europe, the EMA has not regulated FMTs for CDI thus far. For other diseases, FMT should be considered strictly experimental, only offered to patients in an investigational setting. Although changes have been demonstrated for patients with metabolic syndrome, further studies have to demonstrate signature groups that can establish long-term effects on insulin resistance while taking confounding factors (diet, weight) into account. The results of randomized trials for IBD are eagerly awaited. Although patients with ulcerative colitis have repeatedly demonstrated a positive attitude towards FMT, caution of physicians is required, as evidence is lacking.
With the increased interest for microbiota and its influence on health and disease, future insights may point to other diseases for which FMT may be beneficial, such as (antibiotic induced) IBS, bacterial overgrowth, autoimmune diseases, multiple sclerosis, allergies, and depression. Although the concept of FMT is promising, current expectations should be dampened until future evidence arises.
Conclusion
With increasing recognition of the role of disturbed microbiota in development of various diseases, influencing and restoring the microbiota may provide proof of the concept that the microbiota is a causative factor in the pathogenesis. To date, FMT is an established treatment modality for recurrent CDIs. Persisting normalization of the disturbed bowel microbiota associated with CDI seems responsible for the therapeutic effect of FMT. New research has to focus on the optimal composition of microbiota given to patients with recurrent CDI. This will lead to better probiotic mixtures, which ultimately eliminate the need for donor screening and donor feces infusion in the future.
In early 2013, the US Food and Drug Administration (FDA) required an investigational new drug (IND) application for each FMT. This greatly restricted the implementation of routine FMTs. This policy has since been changed, and the FDA now exercises discretion if they are provided with an extended informed consent. In Europe, the EMA has not regulated FMTs for CDI thus far. For other diseases, FMT should be considered strictly experimental, only offered to patients in an investigational setting. Although changes have been demonstrated for patients with metabolic syndrome, further studies have to demonstrate signature groups that can establish long-term effects on insulin resistance while taking confounding factors (diet, weight) into account. The results of randomized trials for IBD are eagerly awaited. Although patients with ulcerative colitis have repeatedly demonstrated a positive attitude towards FMT, caution of physicians is required, as evidence is lacking.
With the increased interest for microbiota and its influence on health and disease, future insights may point to other diseases for which FMT may be beneficial, such as (antibiotic induced) IBS, bacterial overgrowth, autoimmune diseases, multiple sclerosis, allergies, and depression. Although the concept of FMT is promising, current expectations should be dampened until future evidence arises.
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