Table 1

Schedule of enrolment, interventions and assessments

Study periodEnrolmentIntervention periodFollow-up period
Time pointWeek −20-pointWeek 4Week 8Week 12Week 16Week 24
Eligibility screening××
Informed consent×
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)××××
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.