Table 2

Summary of recommendations

Outpatient evaluation
  • Remote assessment (medical interview by voice or video call)

  • If remote assessment not possible: Checkpoint at entrance (body temperature; patients must wear surgical mask; hand wash; no company admitted)

  • COVID-19 screening (exposure and medical history, symptoms, laboratory analyses)

  • If clinical suspect of COVID-19, nasopharyngeal swab must be performed

Inpatient evaluation
  • Exclude COVID-19 (nasopharyngeal swab, laboratory exams, if fever or respiratory distress perform chest CT scan)

  • Isolation (contact precautions and droplets in air); visitors not admitted

  • If patients positive for COVID-19:

    • Dedicated COVID-19 wards and dedicated healthcare professionals

    • Dedicated radiology and invasive procedures

    • Evaluate the risk of complications or infective issues compared with the benefit of FMT procedure

Donor screening
  • Remote assessment (screening medical interview by voice or video call)

  • COVID-19 screening (exposure to confirmed cases, medical history, symptoms)

  • Laboratory examinations (standard blood and stool tests plus nasopharyngeal swab and serology for SARS-CoV-2)

Stool donation
  • Repeat standard and COVID-19 screening interview (preferably remote assessment prior to access to the clinic)

  • Checkpoint at entrance (body temperature, subjects must wear surgical mask, hand wash, company forbidden)

  • Direct stool testing for SARS-CoV-2 and/or common pathogens; quarantine approach as potential alternative

Stool handling
  • Stool transferred to microbiological laboratory by dedicated health workers

  • Retention of stool samples for 'look-back' testing is recommended

  • Stool processing conforms to local standard operating procedures and biosafety protocols; at minimum, biosafety level 2 is advised

FMT by endoscopic procedure
  • Access to the endoscopy service:

    • Differentiate logistic pathways of patient access according to COVID-19 diagnosis

    • Outpatients can be accompanied by a caregiver

    • Checkpoint at entrance (body temperature, patients and caregiver must wear surgical mask, hand wash)

  • Management of the endoscopic procedure:

    • Differentiate endoscopic and recovery room (dedicated rooms for COVID-19 patients)

    • Dedicated healthcare professionals for COVID-19

    • Staff present in the endoscopic room must be protected for drops in air (wear FFP2, protect eyes, wear double gloves, wear shields or hats)

    • Patients should wear surgical mask

  • Discharge of the patient:

    • Keep differentiated logistic pathways according to COVID-19 diagnosis

    • Inpatient return to the ward accompanied by dedicated healthcare workers

    • Outpatient discharged after brief observation, medical and nurse staff report follow-up instructions to caregivers via remote contact

Follow-up Follow-up visits should preferably take place via remote assessment (medical interview by voice or video call, reports sent by email), outpatient visits should be limited to cases where in-presence assessment is mandatory
Research activities
  • Ongoing trials should adapt their protocols according to the changing status of COVID-19

  • Upcoming trials should be designed taking into account the same security measures proposed in this document for clinical practice

  • Virtual visits (especially those after treatment) should be considered rather than in-person assessments

  • Donor recruitment protocols and workflows must follow international guidelines

  • The use of multi-donor FMT should only be considered within a FMT trial if there is strict adherence to proposed security measures

  • The use of frozen stools is preferred over fresh material, although SARS-CoV-2 can probably survive the storage conditions

  • Highly safe environment (at least biosafety level 2) for stool manipulation

  • Use of registers, application of the same strict traceability protocols already recommended for clinical practice