Target area | Feasibility target |
---|---|
Recruitment | Successful enrolment of n = 15 participants across a 6-month active recruitment period |
Retention | A minimum of n = 10 participants to complete study until the 8-week primary endpoint (i.e. a 33% attrition rate). |
Adherence to protocol | Participants should: 1) Receive two of the total four enemas 2) Attend their baseline, week 2 and week 8 appointments 3) Provide baseline and week 2 stool samples |
Safety | Nil severe and/or serious adverse events rated as likely due to study intervention in the active FMT group. |
Adequacy of blinding | The best achievable outcome for adequacy blinding is participants and researchers correctly guessing allocation at a rate of 50% (the rate due to chance). Whilst we are not likely to be statistically powered to measure this outcome, we aim to reach an outcome approaching 50%. |