Chronic Kidney DiseaseNCT02364869
Prebiotic in Chronic Kidney Disease Patients
A study testing Fructooligosaccharide and Maltodextrin in people with Chronic Kidney Disease, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
This 12-week double-blind randomized controlled clinical trial aims to investigate the effect of a prebiotic (fructooligosaccharide - FOS) on serum and urinary levels of uremic toxins (p-cresyl sulfate and indoxyl sulfate) of non-dialysis dependent CKD patients, and the impact of such intervention on cardiovascular… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Fructooligosaccharide and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- May 2015to Dec 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 80 years
- Estimated glomerular filtration rate between 45 to 15 ml/min/1,73m².
Who cannot join
- diabetes mellitus, malignance, severe liver disease, autoimmune diseases, congestive heart failure class III / IV, HIV, history of gastrointestinal disease
- use of phosphate binders, laxatives or prebiotic, probiotic, symbiotic, antibiotics, immunosuppressants and / or anti-inflammatory drugs three months preceding the study.
- patients using laxatives who refuse to stop treatment during the follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Prebiotic (Fructooligosaccharide) on Uremic Toxins and Cardiovascular Markers of Chronic Kidney Disease Patients
This 12-week double-blind randomized controlled clinical trial aims to investigate the effect of a prebiotic (fructooligosaccharide - FOS) on serum and urinary levels of uremic toxins (p-cresyl sulfate and indoxyl sulfate) of non-dialysis dependent CKD patients, and the impact of such intervention on cardiovascular markers, intestinal permeability, endotoxemia and inflammatory response.
Read the detailed description
Intestinal microbiome has been considered a new therapeutic target for chronic kidney disease (CKD) due to its potential role on the metabolic disturbances associated to the disease. The abnormalities in the microbiota, frequently found in patients with CKD, contribute to the accumulation of uremic toxins derived from the unbalanced fermentation of nitrogen compounds in relation to the non-digestible carbohydrates. Among them, p-cresyl sulfate and indoxyl sulfate have been associated with inflammation, kidney disease progression, endothelial dysfunction and increased risk of death in this population. Preliminary studies especially on hemodialysis have shown that the use of prebiotic, probiotic and symbiotic may represent a promising intervention due to their beneficial effect as modulators of the intestinal microbiota that might promote a reduction on serum concentration of p-cresyl sulfate and indoxyl sulfate. In comparison to probiotic, prebiotic have the advantage to stimulate the host's microbiota and to occur naturally in several foods. In the context of CKD, the use of prebiotics has been poorly investigated. Therefore, the primary aim of this study is to investigate the effect of a prebiotic (fructooligosaccharide - FOS) on serum and urinary levels of p-cresyl sulfate and indoxyl sulfate of non-dialysis dependent CKD patients. As a secondary aim we will investigate the impact of such intervention on cardiovascular markers, intestinal permeability, endotoxemia and inflammatory response. This is a 12-week double-blind randomized controlled clinical trial. Fifty non-diabetic patients with CKD stages 3a and 4 will be randomly assigned to a 12 g/day of FOS or maltodextrin (placebo). The serum and urinary concentrations of p-cresyl sulfate and indoxyl sulfate will be determined by high performance liquid chromatography (HPLC). The assessment of endothelial function includes ultrasonography of the brachial artery, measurement of plasma and urinary nitric oxide, monocyte chemoattractant protein 1 (MCP1), stromal cell-derived factor 1 alpha (SDF1α), oxide - trimethylamine N- (TMAO), ambulatory blood pressure monitoring (ABPM) and pulse wave velocity (PWV). The serum intestinal trophic markers (glucagon-like peptide 2 - GLP2 - and epidermal growth factor - EGF), intestinal permeability (Zonulin), endotoxemia and inflammation (IL-6 and CRP) will be determined by ELISA. Food intake will be assessed by 3-day food records. Protein intake will be estimated by calculating the protein equivalent of nitrogen appearance (PNA). The Bristol Scale, the Roma III Criteria and the Gastrointestinal Symptoms Rating Scale will be applied to evaluate gastrointestinal effects during the follow-up. The subjective global assessment questionnaire, the spectroscopic bioimpedance analysis and the handgrip strength will be applied to evaluate the nutritional status of the patients.
- Conditions
- Chronic Kidney Disease
- Being tested
- Fructooligosaccharide, Maltodextrin
- Keywords
- P-cresyl sulfate, Indoxyl sulfate, Intestine, Endothelial function
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FructooligosaccharideDietary supplement
Also called Prebiotic
Patients will be evaluated at baseline, week 6 and 12.
MaltodextrinDietary supplement
Placebo Comparator. Patients will be evaluated at baseline, week 6 and 12.
| Study group | Role | What they receive |
|---|---|---|
| Fructooligosaccharide | Experimental | 12g daily, for 12 weeks Receives: Dietary Supplement: Fructooligosaccharide |
| Maltodextrin | Placebo comparator | 12g daily, for 12 weeks Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uremic toxicity evaluated by serum and urinary levels of p-cresyl sulfate and indoxyl sulfate
Measured: 12 weeks
Secondary outcomes (13)
Endotoxemia measured by serum levels of lipopolysaccharides
Measured: 12 weeks
Intestinal permeability evaluated by serum levels of Zonulin
Measured: 12 weeks
Intestinal epithelium evaluated by serum levels of glucagon-like peptide 2 (GLP2)
Measured: 12 weeks
Intestinal epithelium evaluated by serum levels of epidermal growth factor (EGF).
Measured: 12 weeks
Inflammation measured by serum levels of Interleukin-6 (IL-6)
Measured: 12 weeks
Inflammation measured by serum levels of c-reactive protein (CRP)
Measured: 12 weeks
Endothelial function evaluated by ultrasonography of the brachial artery
Measured: 12 weeks
Endothelial function evaluated by blood pressure monitoring (ABPM)
Measured: 12 weeks
Endothelial function evaluated by pulse wave velocity (PWV).
Measured: 12 weeks
Endothelial function evaluated by plasma and urinary levels of nitric oxide
Measured: 12 weeks
Endothelial function evaluated by plasma and urinary levels of monocyte chemoattractant protein 1 (MCP1)
Measured: 12 weeks
Endothelial function evaluated by plasma and urinary levels of stromal cell-derived factor 1 alpha (SDF1α)
Measured: 12 weeks
Endothelial function evaluated by plasma and urinary levels of oxide - trimethylamine N- (TMAO)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2016
- Study completionDec 2016
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 DiseaseStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Federal do Paraná, Pontifícia Universidade Católica do Paraná
- Responsible party
- Principal investigator, Lilian Cuppari, Federal University of São Paulo
- Investigators
- Lilian Cupari, PhD, Principal investigator, Affiliate professor of Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02364869
- Sponsor's protocol ID
- MCTI/CNPQ: 449614/2014-0
- Status last verified
- Apr 2017
- First submitted
- 13 Jan 2015
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Cooper TE, Khalid R, Chan S, Craig JC, Hawley CM, Howell M, Johnson DW, Jaure A, Teixeira-Pinto A, Wong G. Synbiotics, prebiotics and probiotics for people with chronic kidney disease. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD013631. doi: 10.1002/14651858.CD013631.pub2.
PubMed 37870148
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prebiotic (Fructooligosaccharide) on Uremic Toxins and Cardiovascular Markers of Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT02364869
- Acronym / sponsor ID
- MCTI/CNPQ: 449614/2014-0
- Conditions
- Chronic Kidney Disease
- Keywords
- P-cresyl sulfate, Indoxyl sulfate, Intestine, Endothelial function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Universidade Federal do Paraná, Pontifícia Universidade Católica do Paraná
- Study start
- May 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 18 Feb 2015 (estimated)
- 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.
This 12-week double-blind randomized controlled clinical trial aims to investigate the effect of a prebiotic (fructooligosaccharide - FOS) on serum and urinary levels of uremic toxins (p-cresyl sulfate and indoxyl sulfate) of non-dialysis dependent CKD patients, and the impact of such intervention on cardiovascular markers, intestinal permeability, endotoxemia and inflammatory response.
Detailed description
Intestinal microbiome has been considered a new therapeutic target for chronic kidney disease (CKD) due to its potential role on the metabolic disturbances associated to the disease. The abnormalities in the microbiota, frequently found in patients with CKD, contribute to the accumulation of uremic toxins derived from the unbalanced fermentation of nitrogen compounds in relation to the non-digestible carbohydrates. Among them, p-cresyl sulfate and indoxyl sulfate have been associated with inflammation, kidney disease progression, endothelial dysfunction and increased risk of death in this population. Preliminary studies especially on hemodialysis have shown that the use of prebiotic, probiotic and symbiotic may represent a promising intervention due to their beneficial effect as modulators of the intestinal microbiota that might promote a reduction on serum concentration of p-cresyl sulfate and indoxyl sulfate. In comparison to probiotic, prebiotic have the advantage to stimulate the host's microbiota and to occur naturally in several foods. In the context of CKD, the use of prebiotics has been poorly investigated. Therefore, the primary aim of this study is to investigate the effect of a prebiotic (fructooligosaccharide - FOS) on serum and urinary levels of p-cresyl sulfate and indoxyl sulfate of non-dialysis dependent CKD patients. As a secondary aim we will investigate the impact of such intervention on cardiovascular markers, intestinal permeability, endotoxemia and inflammatory response. This is a 12-week double-blind randomized controlled clinical trial. Fifty non-diabetic patients with CKD stages 3a and 4 will be randomly assigned to a 12 g/day of FOS or maltodextrin (placebo). The serum and urinary concentrations of p-cresyl sulfate and indoxyl sulfate will be determined by high performance liquid chromatography (HPLC). The assessment of endothelial function includes ultrasonography of the brachial artery, measurement of plasma and urinary nitric oxide, monocyte chemoattractant protein 1 (MCP1), stromal cell-derived factor 1 alpha (SDF1α), oxide - trimethylamine N- (TMAO), ambulatory blood pressure monitoring (ABPM) and pulse wave velocity (PWV). The serum intestinal trophic markers (glucagon-like peptide 2 - GLP2 - and epidermal growth factor - EGF), intestinal permeability (Zonulin), endotoxemia and inflammation (IL-6 and CRP) will be determined by ELISA. Food intake will be assessed by 3-day food records. Protein intake will be estimated by calculating the protein equivalent of nitrogen appearance (PNA). The Bristol Scale, the Roma III Criteria and the Gastrointestinal Symptoms Rating Scale will be applied to evaluate gastrointestinal effects during the follow-up. The subjective global assessment questionnaire, the spectroscopic bioimpedance analysis and the handgrip strength will be applied to evaluate the nutritional status of the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fructooligosaccharide | Experimental | Dietary Supplement: Fructooligosaccharide12g daily, for 12 weeks |
| Maltodextrin | Placebo comparator | Dietary Supplement: Maltodextrin12g daily, for 12 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 to 80 years
- Estimated glomerular filtration rate between 45 to 15 ml/min/1,73m².
Key exclusion criteria (3 listed)
- diabetes mellitus, malignance, severe liver disease, autoimmune diseases, congestive heart failure class III / IV, HIV, history of gastrointestinal disease
- use of phosphate binders, laxatives or prebiotic, probiotic, symbiotic, antibiotics, immunosuppressants and / or anti-inflammatory drugs three months preceding the study.
- patients using laxatives who refuse to stop treatment during the follow-up
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 |
|---|---|---|
| FructooligosaccharideAlso: PrebioticPatients will be evaluated at baseline, week 6 and 12. | Dietary supplement | Fructooligosaccharide |
| MaltodextrinPlacebo Comparator. Patients will be evaluated at baseline, week 6 and 12. | Dietary supplement | Maltodextrin |
Primary outcome
Uremic toxicity evaluated by serum and urinary levels of p-cresyl sulfate and indoxyl sulfate
Time frame: 12 weeks
13 secondary outcomes
Endotoxemia measured by serum levels of lipopolysaccharides
Time frame: 12 weeks
Intestinal permeability evaluated by serum levels of Zonulin
Time frame: 12 weeks
Intestinal epithelium evaluated by serum levels of glucagon-like peptide 2 (GLP2)
Time frame: 12 weeks
Intestinal epithelium evaluated by serum levels of epidermal growth factor (EGF).
Time frame: 12 weeks
Inflammation measured by serum levels of Interleukin-6 (IL-6)
Time frame: 12 weeks
Inflammation measured by serum levels of c-reactive protein (CRP)
Time frame: 12 weeks
Endothelial function evaluated by ultrasonography of the brachial artery
Time frame: 12 weeks
Endothelial function evaluated by blood pressure monitoring (ABPM)
Time frame: 12 weeks
Endothelial function evaluated by pulse wave velocity (PWV).
Time frame: 12 weeks
Endothelial function evaluated by plasma and urinary levels of nitric oxide
Time frame: 12 weeks
Endothelial function evaluated by plasma and urinary levels of monocyte chemoattractant protein 1 (MCP1)
Time frame: 12 weeks
Endothelial function evaluated by plasma and urinary levels of stromal cell-derived factor 1 alpha (SDF1α)
Time frame: 12 weeks
Endothelial function evaluated by plasma and urinary levels of oxide - trimethylamine N- (TMAO)
Time frame: 12 weeks
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 7 Apr 2017.
- Derived from this study: PubMed 37870148Cooper TE, Khalid R, Chan S, Craig JC, Hawley CM, Howell M, Johnson DW, Jaure A, Teixeira-Pinto A, Wong G. Synbiotics, prebiotics and probiotics for people with chronic kidney disease. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD013631. doi: 10.1002/14651858.CD013631.pub2.
- Individual participant dataSharing planned: Undecided
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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.
Lilian Cupari, PhD principal investigator
Affiliate professor of Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fructooligosaccharide and Maltodextrin in people with Chronic Kidney Disease, run by Federal University of São Paulo 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 2 inclusion and 3 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 7 Apr 2017. 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?
Uremic toxicity evaluated by serum and urinary levels of p-cresyl sulfate and indoxyl sulfate (time frame: 12 weeks). 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 NCT02364869, 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 7 Apr 2017.