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Table 4 Feasibility targets

From: Safety and feasibility of faecal microbiota transplant for major depressive disorder: study protocol for a pilot randomised controlled trial

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%.