Chronic Kidney DiseasesNCT05336305
Polydextrose for Patients With Chronic Kidney Disease
A study testing Polydextrose in people with Chronic Kidney Diseases and Constipation, run by Universidade Federal Fluminense at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Kidney Diseases, Constipation
- What is being tested?
- Polydextrose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Mar 2021to 30 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Chronic Kidney Disease
- Hemodialysis patients for more than 6 months
- Aged 18 years or older
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Kidney Diseases, Constipation
- Being tested
- Polydextrose
- Medical subject headings
- Renal Insufficiency, Chronic, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolydextroseDietary supplement
Administration of 3g polydextrose per day, for 2 months
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | Administration of corn starch daily for 2 months Receives: Dietary Supplement: Polydextrose |
| polydextrose | Experimental | Administration of 12g polydextrose daily for 2 months Receives: Dietary Supplement: Polydextrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change constipation status after supplementation with polydextrose
Stool frequency and Bristol Stool Form
Measured: 2 months
Change in cytokines plasma levels measured by ELISA after supplementation with polydextrose
cytokines levels
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start30 Mar 2021
- Primary completion30 May 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal Fluminense
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Denise Mafra, Universidade Federal Fluminense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05336305
- Sponsor's protocol ID
- DeniseMafra15
- Status last verified
- Apr 2022
- First submitted
- 6 Mar 2022
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37321430
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Polydextrose Supplementation on Constipation in Patients Undergoing Hemodialysis
- ClinicalTrials.gov ID
- NCT05336305
- Acronym / sponsor ID
- DeniseMafra15
- Conditions
- Chronic Kidney Diseases, Constipation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidade Federal FluminenseUniversity, hospital or other
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Dietary Supplement: PolydextroseAdministration of corn starch daily for 2 months |
| polydextrose | Experimental | Dietary Supplement: PolydextroseAdministration of 12g polydextrose daily for 2 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of Chronic Kidney Disease
- Hemodialysis patients for more than 6 months
- Aged 18 years or older
Key exclusion criteria (7 listed)
- Patients pregnant
- Smokers
- Using antibiotics in the last 3 months
- Autoimmune diseases
- Clinical diagnosis of infectious diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolydextroseAdministration of 3g polydextrose per day, for 2 months | Dietary supplement | Placebo Group, polydextrose |
Primary outcome
Change constipation status after supplementation with polydextrose
Time frame: 2 months
Stool frequency and Bristol Stool Form
Change in cytokines plasma levels measured by ELISA after supplementation with polydextrose
Time frame: 2 months
cytokines levels
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Derived from this study: PubMed 37321430Borges 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polydextrose in people with Chronic Kidney Diseases and Constipation, run by Universidade Federal Fluminense at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change constipation status after supplementation with polydextrose (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05336305, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.