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OpenTrials
Completed

NCT Number: NCT05336305

Polydextrose for Patients With Chronic Kidney Disease

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.

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Key information

Conditions

Chronic Kidney Diseases Chronic Disease Constipation Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Signs and Symptoms, Digestive Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Denise Mafra

Rio de Janeiro, 22260050, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polydextrose

Dietary Supplement

Administration of 3g polydextrose per day, for 2 months

Primary outcomes

  1. Change constipation status after supplementation with polydextrose

    Time frame: 2 months

    Stool frequency and Bristol Stool Form

  2. Change in cytokines plasma levels measured by ELISA after supplementation with polydextrose

    Time frame: 2 months

    cytokines levels

Sponsors and collaborators

Lead sponsor

Universidade Federal Fluminense

Other

Registry information

Official study title

Effects of Polydextrose Supplementation on Constipation in Patients Undergoing Hemodialysis

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 20, 2022
Registry last updated
Apr 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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