Polydextrose for Patients With Chronic Kidney Disease

April 12, 2022 updated by: Denise Mafra, Universidade Federal Fluminense

Effects of Polydextrose Supplementation on Constipation in Patients Undergoing Hemodialysis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RJ
      • Rio de Janeiro, RJ, Brazil, 22260050
        • Denise Mafra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Group
Administration of corn starch daily for 2 months
Dietary supplement: Polydextrose
Administration of 3g polydextrose per day, for 2 months
Experimental: polydextrose
Administration of 12g polydextrose daily for 2 months
Dietary supplement: Polydextrose
Administration of 3g polydextrose per day, for 2 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change constipation status after supplementation with polydextrose
Time Frame: 2 months
Stool frequency and Bristol Stool Form
2 months
Change in cytokines plasma levels measured by ELISA after supplementation with polydextrose
Time Frame: 2 months
cytokines levels
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal Fluminense

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2021

Primary Completion (Actual)

May 30, 2021

Study Completion (Actual)

October 30, 2021

Study Registration Dates

First Submitted

March 6, 2022

First Submitted That Met QC Criteria

April 12, 2022

First Posted (Actual)

April 20, 2022

Study Record Updates

Last Update Posted (Actual)

April 20, 2022

Last Update Submitted That Met QC Criteria

April 12, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DeniseMafra15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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