Table 3.

The study visits with planned activities

Visit	0	*	X	2+3	4	X	5	6	7+8	9	X	10	11
Study week	?	−2	−1	*	†	3	5	8	9	10	11	13	32
Eligibility evaluation (E)/randomisation (R)/wrap-up visit (W)*	E	R											W
Colon enema with the study substance (active microbiota or placebo)				XX					XX
Irritable bowel syndrome severity scale score		X	X			X	X	X			X	X	X
Weight, height, bioimpedance		X			X		X			X		X	X
Detailed anthropometry		X					X					X	X
Serum workup, archiving serum+plasma		X			X					X			X
Psychological evaluation		X											X
Dietary questionnaire and advice, evaluation of food records†					X					X
Stool samples for microbiome analysis	X	X	X		X	X	X	X		X	X	X	X

*Here, the patient is offered a roll-over into an observational study with active microbiota administration. The patients will be informed of this option at the start of the study and regularly reminded.

†For IBS-SSS questionnaires assessing the primary outcome, please see the intervention scheme in figure 2. Their administering is not linked to study visits.

IBS-SSS, Irritable Bowel Syndrome Severity Symptom Score.