Title |
Faecal microbiota transplantation: a regulatory hurdle?
|
---|---|
Published in |
BMC Gastroenterology, November 2017
|
DOI | 10.1186/s12876-017-0687-5 |
Pubmed ID | |
Authors |
Frederick Verbeke, Yorick Janssens, Evelien Wynendaele, Bart De Spiegeleer |
Abstract |
During faecal microbiota transplantation, stool from a healthy donor is transplanted to treat a variety of dysbiosis-associated gut diseases. Competent authorities are faced with the challenge to provide adequate regulation. Currently, regulatory harmonization is completely lacking and authorities apply non-existing to most stringent requirements. A regulatory approach for faecal microbiota transplantation could be inserting faecal microbiota transplantation in the gene-, cell- and tissue regulations, including the hospital exemption system in the European Advanced Therapy Medicinal Products regulation, providing a pragmatic and efficacy-risk balanced approach and granting all patients as a matter of principle access to this therapy. |
X Demographics
Geographical breakdown
Country | Count | As % |
---|---|---|
Belgium | 3 | 75% |
Unknown | 1 | 25% |
Demographic breakdown
Type | Count | As % |
---|---|---|
Members of the public | 3 | 75% |
Practitioners (doctors, other healthcare professionals) | 1 | 25% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 67 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Researcher | 10 | 15% |
Student > Ph. D. Student | 9 | 13% |
Student > Master | 5 | 7% |
Student > Doctoral Student | 4 | 6% |
Student > Bachelor | 4 | 6% |
Other | 13 | 19% |
Unknown | 22 | 33% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 15 | 22% |
Agricultural and Biological Sciences | 8 | 12% |
Immunology and Microbiology | 7 | 10% |
Biochemistry, Genetics and Molecular Biology | 4 | 6% |
Nursing and Health Professions | 2 | 3% |
Other | 7 | 10% |
Unknown | 24 | 36% |