Table 1

Schedule of enrolment, interventions and assessments

Study period	Enrolment		Intervention period			Follow-up period
Time point	Week −2	0-point	Week 4	Week 8	Week 12	Week 16	Week 24
Eligibility screening	×	×
Informed consent	×
Randomisation		×
Primary outcome
Mean weekly SBMs*	×		×	×	×	×	×
Secondary outcomes
Mean weekly BMs*	×		×	×	×	×	×
Mean weekly stool consistency*	×		×	×	×	×	×
Mean weekly straining*	×		×	×	×	×	×
Weekly emergency defecation drugs usage*	×		×	×	×	×	×
UPDRS-Ⅱ and UPDRS-Ⅲ		×		×		×	×
Gait speed (20 m walk)		×		×		×	×
VAS		×	×	×	×	×	×
AEs			×	×	×	×	×
Compliance evaluation			×	×	×	×	×

*The results are based on the stool diary, which records the patient’s stool for 2 weeks. Therefore, each stool diary recording time is −2-0 weeks, 4-5 weeks, 8-9 weeks, 12-13 weeks, 16-17 weeks and 23-24 weeks.
AEs, adverse events; BMs, bowel movements; SBMs, spontaneous bowel movements; UPDRS, Unified Parkinson’s Disease Rating Scale; VAS, Visual Analogue Scale.