Studies on the effects of polydextrose intake on constipation in Japanese dialysis patients: a triple-blind randomized controlled trial

Not Applicable

• Conditions: Constipation in chronic hemodialysis patients

• Registration Number: JPRN-UMIN000011380
• Lead Sponsor: Heisei Hidaka clinic

Brief Summary

The PDX group had significantly increased stool frequency compared to before the PDX intake period: 7.0, 5.0, 8.0, 8.5 bowel movements per week during the PDX study period (week 1-week 4) and 7.3 bowel movements after the end of the study period (p < 0.01).

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-11
• Study Completion: 2013-08-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients with organic bowel diseases (e.g.; inflammatory bowel disease or colon cancer) 2) Patients who start or change the usage of P, K, cholesterol-binding agents during the study 3) Patients already treated with dietary fibers or Lactobacillus preparations as a supplement 4) Patients hospitalized during the study 5) When an appearance of side effects which seem to be related with dietary fiber mini-jelly or the placebo jelly during the study 6) Patients uncontrolled by hemodialysis during the study 7) Patients showing remarkably poor bowel movements during the study 8) Patients determined by doctors that the study continuation is inappropriate

Study & Design

• Study Type: Interventional
• Study Design: Not specified