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NCT04961164Completed

Resistant Starch Prebiotic Effects in Chronic Kidney Disease

A Randomized Double-Blind Cross-over Trial to Study the Effects of Resistant Starch Prebiotic Effects in Chronic Kidney Disease (ReSPECKD)

Source: ClinicalTrials.gov · Last updated 17 Mar 2025

Brief summary (registry, in English)

In patients with Chronic Kidney Disease (CKD), there is a buildup of nitrogenous uremic toxins of gut microbiome origin, which can contribute to uremic symptoms, reduced quality of life, and earlier progression to dialysis. The goal of this project is to investigate whether the consumption of resistant potato starch (RPS) as an adjunctive therapy to current standard of CKD care will reduce uremic toxins and symptoms by altering the gut microbiota in patients with CKD.

Status (registry)
Completed
Study type
Interventional
Enrollment
50 (actual)
First submitted
26 Oct 2020
Start date
27 Sept 2022
Primary completion date
20 Nov 2024
Lead sponsor
University of Manitoba
NCT number
NCT04961164

What you commit to

  • Study type: Interventional
  • Participants enrolled: 50
  • From 27 Sept 2022 to the primary completion date, 20 Nov 2024
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants taking medications which inhibit peristaltic movement (e.g. opioids,loperamide).

Other illness

  • Participants who indicates they are allergic to potatoes or corn
  • History of renal transplant, ongoing dialysis, use of antibiotics (last 3-months), bowel diseases, cancer, surgically removed bowel, or any gastrointestinal surgery (e.g. intestinal resection, gastric bypass, colorectal surgery)
  • Participants with abnormal constrictions of the gastrointestinal tract, diseases of the oesophagus and/or the superior opening of the stomach (cardia), potential or existing intestinal blockage, paralysis of the intestine, megacolon, faecal impaction, appendicitis, a sudden change in bowel habits that has persisted for more than 2 weeks, undiagnosed rectal bleeding, or failure to defaecate following the use of another laxative prod.

Lab values

  • Participants with uncontrolled diabetes with a hemoglobin A1C \> 10%.
  • Participants with severe anemia (hemoglobin less than 70).

Other

  • The participant is cognitively impaired and cannot give consent or participate in the group program
  • The participant has an existing relationship with the research team, such as supervisory relationship (student, employee) or familial relationship (child, spouse, etc)
  • Participants who indicate that they cannot consume study treatments.
  • Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
  • Inability to consume treatment due to swallowing or GI issues and inability to obtain written informed consent.
  • Participating in another interventional trial that could influence the intervention or outcome of this trial.
  • Participants who consume probiotic supplements.
  • Participants taking other fiber supplements or able to maintain high fiber/adequate fiber intake through diet.

Who the study is looking for

  • Participant is willing and able to give informed consent for participation in the trial.
  • Participant has the ability to speak and read English.
  • Male or Female, aged 18 years or above. Females of child-bearing potential must agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include: Hormonal contraceptives including oral contraceptives, hormone birth control patch, vaginal contraceptive ring, injectable contraceptives, or hormone implant, double-barrier method, intrauterine devices, non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s), vasectomy of partner at least 6 months prior to screening.
  • Estimated glomerular filtration rate (eGFR) \<15 mL/min/1.73m\^2 for the past 3 months
  • In the Investigator's opinion, participant is able and willing to comply with all trial requirements.

Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Chronic Disease Innovation Centre, Seven Oaks Hospital
Coordinator of this site? Confirm its status
WinnipegCanadaUnknown status
Health Science Centre (HSC)
Coordinator of this site? Confirm its status
WinnipegCanadaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.