Table 1

Schedule of assessment time points and study visits

Assessment time points
Visit (V)ScreeningV1V2V3V4V5Study end
Time per session, hours 0.50.250.250.250.51
Study day 017358485+
Study week 00151212+
Enrolment and randomisation       
Eligibility assessmentX      
Randomisation  X    
Implementation       
Questionnaire X   X 
Flocked rectal swab and stool collection kit provided X  X  
Blood collection  X  X 
Flocked rectal swab and stool sample collected  X  X 
Adverse event reporting   XXX 
Review symptoms diary   XXX 
Supplementation       
Tablet distribution  X    
Tablet count   XXX 
Education       
Nutrition education workshop      X