We agree. 8.1.2.3. Management Thank you for this comment. Immediate management after endoscopic administration of the FMT recipient: of FMT should be as per endoscopy unit protocol (strong). Patients should be warned about short term adverse events, in particular the possibility of self-limiting GI symptoms. They should be advised that serious adverse events are rare (strong). After enteral tube administration, patients may have the tube removed and oral water given from 30 minutes (strong). We agree. 8.1.2.4. Definition of A decision regarding cure/remission from CDI should be recorded Thank you for this comment. cure post-FMT for CDI: during follow-up. However, this has no uniformly-agreed definition, and should be decided on a case-by-case basis (strong). We agree. 8.1.2.5. Definition of Treatment failure/recurrence should be defined on a case-by-case We agree on the use of ESCMID guidelines in CDI testing, treatment failure basis. Routine testing for C. difficile toxin after FMT is not and refer to these clearly in Section 8.1.1.1. However, for CDI: recommended, but is appropriate to consider in the case of Section 8.1.2.5 specifically refers to diagnosing failure persistent CDI symptoms/suspected relapse (strong). for CDI rather than initial diagnosis of CDI, and no good When testing is to be performed, we would recommend clinicians uniform definition exists for this. We think that the follow the 2016 European Society of Clinical Microbiology and guidance given, to define treatment failure on a Infectious Diseases (ESCMID) guidelines for CDI testing, which state basis, is the most fair summary of the current literature that no single commercial test can be used as a stand-alone test for on this topic. diagnosing CDI, and recommend a 2-step approach (highly sensitive with reflex to highly specific test). These guidelines recommend performing an initial test with a high negative predicative value; therefore, if negative, no further testing needs to be done.
We agree. 8.1.2.3. Management of the FMT recipient: Immediate management after endoscopic administration of FMT should be as per endoscopy unit protocol (strong). Patients should be warned about short term adverse events, in particular the possibility of self-limiting GI symptoms. They should be advised that serious adverse events are rare (strong). After enteral tube administration, patients may have the tube removed and oral water given from 30 minutes (strong). We agree. Thank you for this comment. 8.1.2.4. Definition of cure post-FMT for CDI: A decision regarding cure/remission from CDI should be recorded during follow-up. However, this has no uniformly-agreed definition, and should be decided on a case-by-case basis (strong). We agree. Thank you for this comment. 8.1.2.5. Definition of treatment failure for CDI: Treatment failure/recurrence should be defined on a case-by-case basis. Routine testing for C. difficile toxin after FMT is not recommended, but is appropriate to consider in the case of persistent CDI symptoms/suspected relapse (strong). When testing is to be performed, we would recommend clinicians follow the 2016 European Society of Clinical Microbiology and Infectious Diseases (ESCMID) guidelines for CDI testing, which state that no single commercial test can be used as a stand-alone test for diagnosing CDI, and recommend a 2-step approach (highly sensitive with reflex to highly specific test). These guidelines recommend performing an initial test with a high negative predicative value; therefore, if negative, no further testing needs to be done. We agree on the use of ESCMID guidelines in CDI testing, and refer to these clearly in Section 8.1.1.1. However, Section 8.1.2.5 specifically refers to diagnosing failure for CDI rather than initial diagnosis of CDI, and no good uniform definition exists for this. We think that the guidance given, to define treatment failure on a basis, is the most fair summary of the current literature on this topic.
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