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NCT05336305 Clinical Trial

Polydextrose for Patients With Chronic Kidney Disease

Chronic Kidney Diseases Clinical Trial

Official title:
Effects of Polydextrose Supplementation on Constipation in Patients Undergoing Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05336305
Other study ID # DeniseMafra15
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 30, 2021
Est. completion date October 30, 2021

Study information
Verified date April 2022
Source Universidade Federal Fluminense
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Constipation is a common complication in patients with chronic kidney disease (CKD), especially in hemodialysis (HD) patients. Reduced intake of fibre-rich food is among the most important causes of constipation. The study aims to investigate the possible influence of polydextrose (PDX) supplementation on constipation in patients with CKD on HD.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date October 30, 2021
Est. primary completion date May 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Clinical diagnosis of Chronic Kidney Disease - Hemodialysis patients for more than 6 months - Aged 18 years or older Exclusion Criteria: - Patients pregnant - Smokers - Using antibiotics in the last 3 months - Autoimmune diseases - Clinical diagnosis of infectious diseases - Clinical diagnosis of Cancer - Clinical diagnosis of AIDS

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Polydextrose
Administration of 3g polydextrose per day, for 2 months

Locations
Country Name City State
Brazil Denise Mafra Rio de Janeiro RJ

Sponsors (1)
Lead Sponsor Collaborator
Universidade Federal Fluminense

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change constipation status after supplementation with polydextrose Stool frequency and Bristol Stool Form 2 months
Primary Change in cytokines plasma levels measured by ELISA after supplementation with polydextrose cytokines levels 2 months
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