NCT05336305

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 20, 2022

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

2 months

First QC Date

March 6, 2022

Last Update Submit

April 12, 2022

Conditions

Chronic Kidney DiseasesConstipation

Outcome Measures

Primary Outcomes (2)

  • Change constipation status after supplementation with polydextrose

    Stool frequency and Bristol Stool Form

    2 months

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

    cytokines levels

    2 months

Study Arms (2)

Placebo Group

PLACEBO COMPARATOR

Administration of corn starch daily for 2 months

Dietary Supplement: Polydextrose

polydextrose

EXPERIMENTAL

Administration of 12g polydextrose daily for 2 months

Dietary Supplement: Polydextrose

Interventions

PolydextroseDIETARY_SUPPLEMENT

Administration of 3g polydextrose per day, for 2 months

Placebo Grouppolydextrose

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Chronic Kidney Disease
  • Hemodialysis patients for more than 6 months
  • Aged 18 years or older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Denise Mafra

Rio de Janeiro, Rio de Janeiro, 22260050, Brazil

Location

Related Publications (1)

  • Borges NA, Sahiun E, Ribeiro-Alves M, Regis B, Mafra D. Effects of Polydextrose Supplementation on Intestinal Function in Hemodialysis Patients: A Double-Blind, Randomized, Placebo-Controlled Trial. J Ren Nutr. 2023 Nov;33(6):747-754. doi: 10.1053/j.jrn.2023.06.008. Epub 2023 Jun 14.

    PMID: 37321430DERIVED

MeSH Terms

Conditions

Renal Insufficiency, ChronicConstipation

Interventions

polydextrose

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

March 6, 2022

First Posted

April 20, 2022

Study Start

March 30, 2021

Primary Completion

May 30, 2021

Study Completion

October 30, 2021

Last Updated

April 20, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)