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Polydextrose for Patients With Chronic Kidney Disease

Primary Purpose

Chronic Kidney Diseases, Constipation

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Polydextrose
Sponsored by
Universidade Federal Fluminense
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Denise Mafra

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Group

polydextrose

Arm Description

Administration of corn starch daily for 2 months

Administration of 12g polydextrose daily for 2 months

Outcomes

Primary Outcome Measures

Change constipation status after supplementation with polydextrose
Stool frequency and Bristol Stool Form
Change in cytokines plasma levels measured by ELISA after supplementation with polydextrose
cytokines levels

Secondary Outcome Measures

Full Information

First Posted
March 6, 2022
Last Updated
April 12, 2022
Sponsor
Universidade Federal Fluminense
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1. Study Identification

Unique Protocol Identification Number
NCT05336305
Brief Title
Polydextrose for Patients With Chronic Kidney Disease
Official Title
Effects of Polydextrose Supplementation on Constipation in Patients Undergoing Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 30, 2021 (Actual)
Primary Completion Date
May 30, 2021 (Actual)
Study Completion Date
October 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal Fluminense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, Constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Administration of corn starch daily for 2 months
Arm Title
polydextrose
Arm Type
Experimental
Arm Description
Administration of 12g polydextrose daily for 2 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Polydextrose
Intervention Description
Administration of 3g polydextrose per day, for 2 months
Primary Outcome Measure Information:
Title
Change constipation status after supplementation with polydextrose
Description
Stool frequency and Bristol Stool Form
Time Frame
2 months
Title
Change in cytokines plasma levels measured by ELISA after supplementation with polydextrose
Description
cytokines levels
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Denise Mafra
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
22260050
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Polydextrose for Patients With Chronic Kidney Disease

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